Vertebral stabilization assembly and method with rigid and semi-rigid members

ABSTRACT

A vertebral stabilization assembly for stabilizing vertebrae is provided. The vertebral stabilization assembly includes a first and a second vertebral screw, a first and second connecting screw, and a connecting member. The first and second vertebral screws each have a shaft provided with a threaded portion operable for threading engagement of the first and second vertebral screws with a first and second vertebra, respectively. Each shaft also has an engaging portion. The first and second connecting screws each have a first end adapted to be received by the engaging portions of the first and second pedicle screws, respectively. The connecting member has a first end connected to the first connecting screw and a second end connected to the second connecting screw for stabilization of the first and second vertebra. A method for stabilizing a lower vertebra and an upper vertebra from an anterior side of the vertebrae using a vertebral stabilization assembly is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of U.S. continuationpatent application Ser. No. 10/823,418, filed Apr. 12, 2004, which is acontinuation of U.S. patent application Ser. No. 10/109,172, filed Mar.28, 2002, which claims priority to U.S. Provisional Patent ApplicationNo. 60/327,118, filed Oct. 3, 2001, U.S. Provisional Patent ApplicationNo. 60/350,259, filed Nov. 2, 2001, U.S. Provisional Patent ApplicationNo. 60/331,857, filed Nov. 20, 2001, and U.S. Provisional PatentApplication No. 60/353,691, filed Jan. 31, 2002, each of which is herebyincorporated by reference herein in its entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to a spinal stabilization andmore specifically, but not by way of limitation, to a vertebralstabilization assembly and method for stabilizing vertebra.

BACKGROUND OF THE INVENTION

The human spine frequently requires surgery to repair deformities orinjuries. Spinal problems may be caused by a trauma to the spinereceived during an accident, excessive strain or stress on the spinefrom physical activities, a sedentary lifestyle and poor posture thatmay place abnormal pressure on the spine, disease or a variety of otherreasons. Spinal fusion is a common surgery intended to alleviate paincaused by these spinal deformities or injuries.

The spinal fusion procedure generally includes removing the disk,packing bone graft between the vertebrae and placing a spinal implant,such as screws attached to a plate, rod or cage, to fuse elements of thespine together. Once the disk is removed and the bone graft is placedbetween the vertebrae, the bone graft will fuse to the vertebrae over aperiod of several months following the surgery.

The purpose of the plate is to stabilize the vertebrae until the bonegraft has become fused to the vertebrae. The plate is positioned toextend between at least two vertebrae. The plate is attached to screwsanchored in each of the adjacent vertebrae, thus immobilizing thedesired portion of the spine. The plate is anchored to the screws eitheron the front, anterior, or back, posterior, sides of the vertebrae.

Another procedure includes utilization of an artificial disc that isarranged and designed to emulate a natural disc. Such “artificialtechniques” can be used in lieu of spinal fusion.

While spinal fusion and artificial disc replacement are potentialsolutions to spine associated problems, these techniques do not comewithout certain disadvantages, which should be quickly recognized bythose skilled in the art.

SUMMARY OF THE INVENTION

From the foregoing it may be appreciated that a need has arisen for avertebral stabilization assembly and method. In accordance with thepresent invention, a vertebral stabilization assembly and method areprovided that substantially eliminate one or more of the disadvantagesand problems outlined above.

According to an aspect of the present invention, a vertebralstabilization assembly for stabilizing vertebrae is provided whichcomprises a first vertebral screw, a first connecting screw, a secondvertebral screw, a second connecting screw, and a connecting member. Thefirst vertebral screw has a shaft provided with a threaded portionoperable for threading engagement of the first vertebral screw with avertebral body of a first vertebra. The shaft of the first vertebralscrew has an engaging portion. The first connecting screw has a firstend and a second end. The first end of the first connecting screw isadapted to be received by the engaging portion of the first vertebralscrew. The second vertebral screw has a shaft provided with a threadedportion operable for threading engagement of the second vertebral screwwith a vertebral body of a second vertebra. The shaft of the secondvertebral screw has an engaging portion. The second connecting screw hasa first end and a second end. The first end of the second connectingscrew is adapted to be received by the engaging portion of the secondvertebral screw. The connecting member has a first end, a second end, afirst location and a second location. The connecting member isconfigured to allow a limited degree of movement between the vertebrae,is operable to couple with the first connecting screw positionable inthe first vertebra at the first location of the connecting member, andis operable to couple with the second connecting screw positionable inthe second vertebra at the second location of the connecting member forstabilization of the first vertebra and the second vertebra.

According to another aspect of the present invention, a method forstabilizing a lower vertebra and an upper vertebra from an anterior sideof the vertebrae using a vertebral stabilization assembly is providedwhich comprises inserting a first vertebral screw, which includes ashaft provided with a threaded portion operable to threadingly engagethe lower vertebra, into the lower vertebra such that a portion of thethreaded portion of the shaft engages a vertebral body portion of thelower vertebra, the shaft of the first vertebral screw having anengaging portion; inserting a first end of the first connecting screwinto the engaging portion of the first vertebral screw; inserting asecond vertebral screw, which includes a shaft provided with a threadedportion operable to threadingly engage the upper vertebra, into theupper vertebra such that a portion of the threaded portion of the shaftengages a vertebral body portion of the upper vertebra, the shaft of thesecond vertebral screw having an engaging portion; inserting a first endof the second connecting screw into the engaging portion of the secondvertebral screw; positioning a connecting member on an anterior side ofthe upper vertebra and the lower vertebra; coupling a connecting memberto a second end of the first connecting screw and to a second end of thesecond connecting screw; and allowing a limited degree of movementbetween the upper and lower vertebra via an arrangement of theconnecting member.

The various embodiments and implementations of the present inventionprovide a profusion of potential technical advantages and benefits. Atechnical advantage of the present invention may include the capabilityto completely eliminate the need for disc replacement and/or spinalfusion by stabilizing vertebrae.

Another technical advantage of the present invention may include thecapability to facilitate the effectiveness of disc replacement and/orspinal fusion by stabilizing vertebrae.

Yet another technical advantage of the present invention may include thecapability to alleviate potential damage to spinal discs by stabilizingvertebrae.

Yet another technical advantage of the present invention may include thecapability to flexibly stabilize vertebrae from an anterior side of thevertebrae.

Other technical advantages may be readily apparent to one skilled in theart after review of following figures and description, associatedherewith.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention and theadvantages thereof, reference is now made to the following briefdescription, taken in connection with the accompanying drawings anddetailed description, wherein like reference numerals represent likeparts, in which:

FIG. 1A is a perspective view of a configuration of a vertebralstabilization assembly illustrated partially in phantom and shownstabilizing an upper and lower vertebra;

FIG. 1B is a perspective view of a configuration of a vertebralstabilization assembly illustrated partially in phantom and shownstabilizing three vertebrae;

FIG. 2 is another perspective view of a configuration of a vertebralstabilization assembly;

FIG. 3 is a side view of a configuration of a connecting member;

FIG. 3A is a side view of another configuration of a connecting member;

FIG. 3B is a side view of a portion of a configuration of a connectingmember shown attached to a connecting screw by a nut;.

FIG. 4 is a side elevational view of a configuration of a pedicle screw;

FIG. 5 is another configuration of a pedicle screw, shown posteriorlypositioned in a lumbar vertebra;

FIG. 6 is a perspective view of a configuration of a guide member foraligning a connecting screw;

FIG. 7 illustrates an alignment of the connecting screw utilizing aguide member;

FIG. 8 illustrates a left side posterior positioning of the pediclescrew and alignment of a connecting screw utilizing a guide member;

FIG. 9 is a top plan view of a configuration of a guide member;

FIG. 10 illustrates an alignment of a connecting screw utilizing a guidemember;

FIG. 11 is a perspective view illustrating a configuration of aconnection of a pedicle screw with a guide member;

FIG. 12 is a flow chart illustrating a method for stabilizing vertebraefrom an anterior side of a vertebrae utilizing a vertebral stabilizationassembly;

FIG. 13 is a perspective view of a configuration of a pedicle screw witha reinforced portion;

FIG. 14 is a perspective view of a configuration of a pedicle screw withat least a first groove and a flat surface on a distal end of a shaft;

FIG. 15 is a cross-sectional view of the configuration of the shaft ofthe pedicle screw illustrated in FIG. 14 taken along line 15-15;

FIG. 16 is a perspective view of a configuration of a cap for attachmentnear the distal end of a pedicle screw;

FIG. 17 is a perspective view of a configuration of a tool forconnection near a distal end of a pedicle screw;

FIG. 18 is a perspective view of a configuration of a tool for use witha vertebral stabilization assembly;

FIG. 19 is a top plan view of a configuration of a bore screw shownobliquely disposed in a vertebra;

FIG. 20 is a top plan view of a configuration of an indicator showndisposed in a bore opening of a vertebra;

FIG. 21 is a top plan view of a configuration of a pedicle screw foranterior placement shown with a distal end of the pedicle screw anchoredin a pedicle portion of the vertebra;

FIG. 22 illustrates a guide member of a vertebral stabilization assemblyattaching adjacent a head portion of an anteriorly placed pedicle screw;

FIG. 23 is a top plan view of a configuration of an engaging portion ofa pedicle screw;

FIG. 24 is a perspective view of a configuration of a pedicle screw withnon-continuous threads;

FIG. 25 is a top view, illustrating placement of dual pedicle screws ina vertebra utilizing a fixation tool;

FIG. 26 is a top plan view of a configuration of dual pedicle screwsanteriorly placed and connected to a connecting screw;

FIG. 27 is a top plan view illustrating a connecting screw extendingacross the vertebra and connected to one or dual pedicle screws;

FIG. 28 is a top plan view of a configuration of a pedicle screw foranterior placement into a vertebra; and

FIG. 29 is a perspective view of a configuration of a vertebralstabilization assembly illustrated partially in phantom and shownstabilizing an upper and lower vertebra.

DETAILED DESCRIPTION OF THE INVENTION

It should be understood at the outset that although an exemplaryimplementation of the present invention is illustrated below, thepresent invention may be implemented using any number of techniques,whether currently known or in existence. The present invention should inno way be limited to the exemplary implementations, drawings, andtechniques illustrated below, including the exemplary design andimplementations illustrated and described herein. Additionally, thedrawings contained herein are not necessarily drawn to scale.

The present invention is not intended to be limited to applications in aspecific region of the spine, and may, in fact, be utilized equally wellwith the cervical, thoracic, lumbar and sacrum vertebrae of the spine.However, for purposes of explanation and brevity, discussion will belimited to the lumbar vertebrae region of the spine. Procedurally,anterior, or entry from the stomach region of the patient, lumbarvertebra surgery provides the surgeon with optimum access to the entireintervertebral disk. Posterior, or entry from the back of the patient,surgery is less preferred since access to the disk is restricted.

FIGS. 1A and 1B generally illustrate configurations of the vertebralstabilization assembly 10. It should be expressly understood that whilespecific component parts will be described with reference to theseconfigurations, other component parts can be utilized in otherconfigurations. Several component parts that can be utilized in otherconfigurations will be described below; and, others will become apparentto one of ordinary skill in the art after review of the specificationherein.

The vertebral stabilization assembly 10 in FIGS. 1A and 1B can begenerally be utilized for stabilizing a plurality of vertebrae of thespine. With reference to the configuration of FIG. 1A, the vertebralstabilization assembly 10 includes a first pedicle screw 12 and a secondpedicle screw 14. The first pedicle screw includes a shaft 16 providedwith a threaded portion 18. The threaded portion 18 of the shaft 16 isoperable for threading engagement of the first pedicle screw 12 with afirst vertebra 20. The shaft 16 of the pedicle screw 12 further includesan engaging portion 22.

The second pedicle screw 14 is substantially similar to the firstpedicle screw 12 in that the second pedicle screw 14 includes a shaft 30substantially similar to the shaft 16 of the first pedicle screw 12. Theshafts 16 and 30 of the first and second pedicle screws 12 and 14,respectively, are substantially cylindrical members. The shaft 30 of thesecond pedicle screw 14 is similarly provided with a threaded portion 32similar to the threaded portion 18 provided on the shaft 16 of the firstpedicle screw 12. The threaded portion 32 of the shaft 30 is operablefor threading engagement of the second pedicle screw 14 with a secondvertebra 34. The shaft 30 of the first pedicle screw 14 is provided withan engaging portion 36.

The shafts 16 and 30 of the first and second pedicle screws 12 and 14are of appropriate length to sufficiently anchor the first and secondpedicle screws 12 and 14 in the first and second vertebra 20 and 34,respectively. The threaded portions 18 and 32 of the first and secondpedicle screws 12 and 14 may have threads similar to those on ordinaryscrews which extend a distance from the shafts 16 and 30 sufficient topromote optimum anchoring of the first and second pedicle screws 12 and14 within the first and second vertebra 20 and 34, respectively. Thefirst and second pedicle screws 12 and 14 are constructed of a rigidmaterial such as, but not limited to, steel, metal, or metal alloys,polymeric material, or a variety of other substantially rigid materialsadapted to promote rigid engagement of the first and second pediclescrews 12 and 14 to the first and second vertebra 20 and 34,respectively.

The vertebral stabilization assembly 10 of FIG. 1A is further providedwith a first connecting screw 40 and a second connecting screw 42. Thefirst and second connecting screws 40 and 42 are substantiallycylindrical members and may be constructed from materials similar tothat of the first and second pedicle screws 12 and 14, such as, but notlimited to, titanium, steel, metal or other metal alloys, substantiallyrigid polymeric material or a variety of other rigid metallic materialsadapted and suitable for these purposes. The first connecting screw 40has a first end 44 adapted to be received by the engaging portion 22 onthe shaft 16 of the first pedicle screw 12. The second connecting screw42 has a first end 46 adapted to be received by the engaging portion 36of the shaft 30 of the second pedicle screw 14.

The vertebral stabilization assembly 10 of FIG. 1A further includes aconnecting member 50, positioned on an anterior side of the first andsecond vertebra 20, 34. The connecting member 50 has a first end 52 anda second end 54. The first end 52 of the connecting member 50 isconnected to the first connecting screw 40 that is positionable in thefirst vertebra 20. The second end 54 of the connecting member 50 isconnected to the second connecting screw 42 positionable in the secondvertebra 34 for stabilization of the first vertebra 20 and the secondvertebra 34.

The vertebral stabilization assembly 10 of FIG. 1B is similar to thevertebral stabilization of FIG. 1A, except that the vertebralstabilization assembly 10 of FIG. 1B includes two connecting members 50between a first vertebra 20, a second vertebra 34, and a third vertebra834. The third vertebra 834, similar to the configuration of FIG. 1A isshown with a third pedicle screw 814 positioned therein. The thirdpedicle 814 can be substantially similar to the first and second pediclescrews 12 and 14, including features such as a shaft 830, a threadedportion 832, and an engaging portion 836. Additionally shown is a thirdconnecting screw 842 that has a first end 846 adapted to be received bythe engaging portion 836 of the shaft 830 of the third pedicle screw814.

In some configurations, the connecting member 50 may be constructed froma variety of rigid materials such as, but not limited to, titanium,steel, metal, or other metal alloys, rigid polymeric material, or otherrigid materials suitable for rigid stabilization between two vertebrae(e.g., the first and second vertebra 20 and 34 by connection to thefirst and second connecting screws 40 and 42) or three vertebrae (e.g.,the first, second, and third vertebra 20, 34, and 834).

In other configurations, the connecting member 50 can be configured forflexible stabilization, allowing a limited degree of movement betweenvertebrae (e.g., between the first and second vertebra 20 and 34 orbetween the first, second, and third vertebra 20, 34, and 834)—viewedalternatively as being configured to limit the degree of movementbetween the vertebrae. As an example of flexible stabilization, intendedfor illustrative purposes only, any of the connecting members 50described herein as well as other connecting members that will becomeapparent to one of ordinary skill in the art can made of flexiblematerial—such flexible materials including, but not limited to a varietyof flexible plastics, metals, and the like. The flexible material of theconnecting member allows a limited amount of movement between thevertebrae—e.g., to emulate natural movement, but to limit movement thatmay damage portions of a natural disc, artificial disc, or fused discconfiguration. As another example of flexible stabilization, (e.g., inconfigurations in which the connecting member 50 spans two or morevertebrae), the connecting member 50 may include a cable 905 stretchedbetween two or more vertebrae (e.g., the first, second, and thirdvertebra 20, 34, and 834). Such a cable 905 may, for example, allow amaximum amount of tension (the tension in the cable 905 precipitated bymovement of the vertebrae in relation to one another). As still anotherexample of flexible stabilization, (e.g., in configurations in which theconnecting member 50 spans two or more vertebrae), the connecting member50 may include one or more hinged or pivoting elements (not shown)disposed between one or more pairs of the one or more vertebrae (e.g.,between the first, second, and third vertebra 20, 34, and 834). Eachhinged or pivoting element (not shown) may be adjustable to allowmovement between vertebrae ranging from no movement (e.g., to preventfurther damage possibly due to failed disc replacement procedure) to asome higher level of movement (e.g., to emulate natural movement, but tolimit movement that may damage portions of a natural disc, artificialdisc, or fused disc configuration). Adjustment of each hinged orpivoting element (not shown) may be performed percutaneously or throughthe skin requiring only a small incision, and avoiding the disadvantagesassociated with large, invasive posterior procedures which requiresignificant interference and dissection of adjacent muscles. Otherconfigurations should become apparent to one of ordinary skill in theart, including not only configurations that are now known, but alsothose that will be later developed.

In flexible stabilization configurations, several benefits will becomeapparent to one of ordinary skill in the art. One such benefit includesa reduction of weight on a disc (either natural or artificiallyconstructed), which in turn can reduce the likelihood of discdegeneration. In some flexible stabilization configurations, theflexible connecting member 50 can be utilized in lieu of discreplacement and/or vertebral fusion procedures. In yet otherconfigurations, the flexible connecting member 50 can be utilized inconjunction with disc replacement and/or vertebral fusion procedures. Insetting forth the above examples, it should be understood that theexamples described above are intended as only exemplifying some of manyconfigurations that can be utilized. Other configurations along with theassociated benefits therewith will become apparent one of ordinary skillin the art after review of the specification. For example, multipleconnecting members 50 can be placed between vertebra. As an example, aconnecting member can be placed on both anterior sides of the vertebra;or, one or more connecting members 50 can be placed on the anterior sidevertebra and one or more connecting members can be placed on theposterior side of the vertebra.

Additionally shown in FIG. 1B are discs 900 and 910. Discs 900 and 910can either be natural discs (e.g., natural vertebral discs of the humanbody) or artificial discs. A variety of different types andconfigurations of artificial discs can be utilized as will becomeapparent to one of ordinary skill in the art—including not only thosethat are now known, but also those that will be later developed. Withillustration of discs 900 and 910, it should be understood that thevertebral stabilization assembly 10 can be utilized with a combinationof natural and artificial discs, artificial disc, alone, or naturaldiscs, alone. The vertebral stabilization assembly 10 can additionallybe utilized with fused discs and combinations of fused, natural, and/orartificial discs.

FIG. 2 illustrates the vertebral stabilization assembly 10,substantially as shown in FIG. 1A, with the first and second vertebra 20and 34 removed from the illustration for the purpose of furtherdescription. It can be seen that the first and second pedicle screws 12and 14 are provided with a head 60 and 62, respectively. The heads 60and 62 of the first and second pedicle screws 12 and 14 may beconfigured to receive a tool, such as, but not limited to, a standardflat or a Phillips-head screw driver, Allen or other wrench connection,or a variety of male to female or female to male temporaryinterconnections for threadingly engaging the first and second pediclescrews 12 and 14 into the first and second vertebra 20 and 34.

In other configurations (not shown) the heads 60 and 62 of the first andsecond pedicle screws 12 and 14 may be configured unlike the head of thestandard screw and instead be unitarily formed, for example,rectangularly from the shaft 16 and 30 for mating engagement with aunique tool adapted to receive the rectangularly-formed shaft.

It will be appreciated that a variety of constructions andconfigurations of the heads 60 and 62 of the first and second pediclescrews 12 and 14 will readily suggest themselves to one of ordinaryskill in the art and may be provided in numerous configurations suchthat a tool may be attached temporarily to the heads 60 and 62 forimparting a rotation upon the first and second pedicle screws 12 and 14.

In the present illustration, the engaging portion 22 of the shaft 16 canbe more easily seen as adapted to receive the first end 44 of the firstconnecting screw 40. The engaging portion 22 of the shaft 16 is athreaded opening formed in the shaft 16 of the first pedicle screw 12and adapted to receive a threaded first end 44 of the first connectingscrew 40. In this manner the first connecting screw 40 threadinglyengages the engaging portion 22 to achieve a rigid locking connectionbetween the first pedicle screw 12 and the first connecting screw 40.

In other configurations (not shown) the engaging portion 22 may be atension connection opening in the shaft 16 for receiving and engaging ina tensioning fashion the first end 44 of the first connecting screw 40.In yet other configurations (not shown) the engaging portion 22 may be alocking assembly adapted to receive the first end 44 of the firstconnecting screw 40 and lock into place upon insertion. The lockingengagement of the engaging portion 22 may be accomplished in a varietyof manners including a keyed design of the engaging portion 22 such thatwhen the first end 44 of the first connecting screw 40 is inserted intothe engaging portion 22 it is locked into place upon rotation of thefirst connecting screw 40.

Yet in other configurations (not shown), the engaging portion 22 may bea modification to the outer surface of the shaft 16 of the first pediclescrew 12 such that the first end 44 of the first connecting screw 40 maybe adapted to receive the engaging portion 22 of the shaft 16 within anopening in the first end 44 of the first connecting screw 40. In thismanner the locking or tensioning mechanism may be retained by the firstend 44 of the first connecting screw 40 for engaging the firstconnecting screw 40 with the first pedicle screw 12.

A number of other connections including spring, ball, or othertensioning connections, as well as, threading, locking, and other matingconnections for engaging the first end 44 of the first connecting screw40 with the engaging portion 22 of the shaft 16 of the first pediclescrew 12 will readily suggest themselves to one of ordinary skill in theart and are within the spirit and scope of the present invention. Itwill be appreciated that the engaging portion 36 of the shaft 30 of thesecond pedicle screw 14 may be constructed substantially identical tothe engaging portion 22 of the shaft 16 of the first pedicle screw 12.For purposes of brevity no further discussion of the engaging portion 36is deemed necessary to enable one of ordinary skill in the art on thevariety of means for engaging the first and second connecting screw 40and 42 with the first and second pedicle screw 12 and 14 in light of thediscussion regarding the engaging portion 22 of the first pedicle screw12.

The first connecting screw 40 is constructed substantially similar tothe second connecting screw 42 and for this reason, only the firstconnecting screw 40 will be discussed and described for purposes ofbrevity. The first connecting screw 40 is connected to the connectingmember 50 near a second end 64 of the first connecting screw 40. Theconnection of the first connecting screw 40 to the connecting member 50may be accomplished in a variety of manners such as, as shown in thepresent illustration, by providing a threaded portion on the second end64 of the first connecting screw 40.

In this manner, a coupling 70 may be coupled to the second end 64 of thefirst connecting screw 40 and attached using a standard nut threadinglyengaged with the threaded portion 66 of the second end 64 of the firstconnecting screw 40. The coupling portion 70 may be provided with anoffset member 74 adapted to receive a rod 76. The offset member 74thereby tensions the portion of the rod 76 extending through the offsetmember 74 for rigid engagement of the rod 76 to the coupling 70.

The tensioning engagement of the rod 76 by the offset member 74 may beaccomplished by providing a screw (not shown), or othertension-imparting structure, threaded through the offset member 74 andinto contact with the portion of the rod 76 extending through the offsetmember 74. The use of the coupling 70 and the rod 76 is a simple anduseful design, according to one aspect, of the connecting member 50 forstabilization of the first and second vertebrae 20 and 34 via the firstand second connecting screws 40 and 42.

It should be appreciated, however, that the connecting member 50 may beaccomplished utilizing a variety of other structural connections to thefirst and second connecting screws 40 and 42. For example, in oneconfiguration (not shown), an opening may extend through the second end64 of the first connecting screw 40. The opening of sufficient diameterto receive the rod 76 there through the opening in the second end 64 ofthe connecting screw 40. A tensioning connection, such as a screw or anut may be utilized to tensionally engage the rod to the second end 64of the first connecting screw 40. Other configurations of the coupling70 may be utilized for these purposes and are within the spirit andscope of the present invention and will readily suggest themselves toone of ordinary skill in the art.

FIG. 3 illustrates a side view of a configuration of a connecting member50 of the vertebral stabilization assembly 10. In this configuration,the connecting member 50 is a bracket 90 having a first opening 92 and asecond opening 94. The bracket 90, as with the various aspects of theconnecting member 50, may be constructed from a variety of substantiallyrigid materials such as titanium, steel, metal or metal alloys, rigidpolymeric material and other substantially rigid materials which may beutilized for these purposes. Alternatively, as referenced above, thebracket 90 can be made of flexible materials such as, but not limited,to flexible plastics, metals, and the like.

The bracket 90 is a substantially flat plate provided with the first andsecond openings extending therethrough for receiving the first andsecond connecting screws 40 and 42. In this manner, the second end 64 ofthe first connecting screw 40 may be caused to extend through the firstopening 92 of the bracket 90. The nut or other similar device 72 canthen be threadingly engaged about the threaded portion 66 and caused toengage the bracket 90 to the second end 64 of the first connecting screw40. Similarly, the second opening 94 may be adapted to receive thesecond connecting screw 42 for attachment thereto.

The symmetrical nature of the vertebral stabilization assembly 10 lendsitself to stabilization of a plurality of vertebrae. For example, thefirst and second pedicle screws 12 and 14 are substantially similar, asare the first and second connecting screws 40 and 42. Thus, it iscontemplated that two or more vertebrae can be stabilized. For example,in other configurations (e.g., similar to FIG. 1B) a third, fourth, ormore pedicle screws may be utilized for engagement of a third, fourth,or more connecting screws for stabilization of a plurality of vertebrae.As such, the connecting member 50, or the bracket 90, shown in FIG. 3,will be provided having appropriate length or with the appropriatenumber of openings to receive each of the connecting screws forstabilizing the desired number of vertebrae.

One advantage of the vertebral stabilization assembly 10 of the presentinvention is that the connecting member 50, whether utilizing thebracket 90 or the coupling 70 with the rod 76 (see FIG. 2), is adaptedfor connection on the anterior or front side of the vertebrae. Theconnecting member 50 according to the present invention has a lowprofile and thus minimizes the interference with soft tissue within theanterior of the patient.

Another advantage of the present invention is that the first pediclescrew 12 engaging the first connecting screw 40 provides for maximumstabilization in the vertebra 20. As such, secure attachment to thevertebra 20 is optimized and greater stabilization can be accomplishedby the innovations provided according to the present invention.Furthermore, the first pedicle screw 12 so connected to the firstconnecting screw 40 has the effect of inhibiting the first pedicle screw12 from backing out of the vertebra 20, as well as preventing the firstconnecting screw 40 from backing out of the vertebra 20 as well.

FIG. 3A illustrates another configuration of the connecting member 50that is similar to the bracket 90, illustrated in FIG. 3. In thisconfiguration the bracket 90 is provided with a single opening 96 havinga first end 97 and a second end 98 extending through the bracket 90. Theopening 96 near the first and second ends 97 and 98 are provided with aplurality of notches 99 adapted for securely receiving a portion of ascrew, such as the second end 64 of the first connecting screw 40.

The bracket 90 is useful where the first connecting screw 40 and thesecond connecting screw 42 are not substantially aligned vertically.Thus, the notches 99 are provided so that the first and secondconnecting screws 40 and 42 may be connected to the bracket 90 atvarious notches 99 on the first and second ends 97 and 98, respectively,of the bracket 90 while maintaining the bracket 90 disposed in asubstantially vertical manner while the first and second connectingscrews 40 and 42 may not be substantially vertical with respect to oneanother.

FIG. 3B illustrates another aspect of the first connecting screw 40shown attached to the connecting member 50, such as the bracket 90,using a capped bolt 104. It can be seen that the second end 64 of thefirst connecting screw 40 is provided with a notch 106 such that thebracket 90 is flush against the notch 106 of the first connecting screw40 for secure attachment thereto. A capped bolt 104 or other low-profileconnectors may be utilized advantageously so as to minimize theinterference and contact of the vertebral stabilization assembly 10 ofthe present invention with any of the soft tissue of the patient.

FIG. 4 illustrates another aspect of the present invention of thepedicle screw, such as the pedicle screw 12, for securing a connectingscrew, such as the first connecting screw 40, of the vertebralstabilization assembly 10 of the present invention. In this aspect thepedicle screw 12, as well as having the shaft 16 having the threadedportion 18 and the engaging portion 22, as previously discussed, furtherincludes a coupling portion 100 provided on the shaft 16.

The coupling portion 100 is adapted to connect a guide member (whichwill be discussed in greater detail with reference to FIG. 6) of thevertebral stabilization assembly. In one aspect the coupling portion 100may be a threaded portion on the outer surface of the shaft 16 near thedistal end 102 of the shaft 16. The guide member may be threadinglyconnected to the coupling portion 100 about the distal end 102 of theshaft 16. In other configurations, however, the coupling portion may bean opening provided in the distal end 102 of the shaft 16 such that aportion of the guide member may be threadingly received within theopening in the distal end 102 of the shaft 16 for threading engagementtherewith the coupling portion 100.

As previously mentioned, the engaging portion 22 of shaft 16 is operableto receive the first connecting screw 40. The engaging portion 22 in oneconfiguration may be provided as an opening on the shaft 16 extendingcompletely through the shaft 16. The purpose of the engaging portion 22,as previously discussed, is to provide stabilizing engagement of thefirst connecting screw 40 with the first pedicle screw 12. As previouslydiscussed, this engagement may be provided in a variety of manners, suchas, but not limited to, a locking engagement, a threading engagement, atensioning or other coupling connection of the first connecting screw 40with the first pedicle screw 12 about the engaging portion 22.

Referring also to FIG. 5 a top view of a vertebra 118, such as a lumbarvertebra, shown with the first pedicle screw 12 set therein. Oneadvantage of the present invention is that the first pedicle screw 12may be placed through a pedicle 120 on a posterior side 122 of thevertebra 118.

Posterior placement through the pedicle 120 of the vertebra 118 providesoptimum stability and anchoring of the first pedicle screw 12 bythreading engagement through the most rigid portions of the vertebra118. Significant problems arise when the first pedicle screw 12 is notwell anchored within the vertebra 118 and alternate placement is thenrequired. Furthermore, stabile anchoring is critical to reduce thelikelihood that the first pedicle screw 12 will back out, or comebackwards out of its placement, of the vertebra 118. The illustratedplacement of first pedicle screw 12 advantageously overcomes thedisadvantages associated with unstable attachment common with anteriorvertebral stabilization systems.

As previously mentioned, the connecting member 50 is positionable on theanterior side 124 of the vertebra 118. Thus, the vertebral stabilizationassembly 10 of the present invention achieves the advantages of anteriorvertebral stabilization, since the connecting member is positioned onthe anterior side 124 of the vertebra 118, while simultaneouslyachieving the stability associated with posterior procedures.

The first pedicle screw 12 may be placed in the vertebra 118,substantially as shown, percutaneously or through the skin requiringonly a small incision, and avoiding the disadvantages associated withlarge, invasive posterior procedures which require significantinterference and dissection of adjacent muscles.

In yet another aspect of the present invention the pedicle screw 12 maybe provided with a cannulated shaft 16 such that a passageway 110extends through the shaft 16 from the head 60 to the distal end 102thereof the shaft 16. By utilizing the passageway 110 extending throughthe shaft 16 of the first pedicle screw 12, a tool (not shown) such as atap or drill bit may be placed through this cannulated portion of theshaft 16 such that the tool or drill bit enters near the head 60 of thefirst pedicle screw 12. The tool is then extended through the passageway110 towards the distal end 102.

The tool may then be utilized to drill through to the anterior side 124of the vertebra 118 for location of the distal end 102 of the pediclescrew 12 from the anterior side 124 of the vertebra 118. Since only asmall distance must be drilled, there is minimal risk to soft tissue orblood vessels. Furthermore, once the tool penetrates the anterior side124 of the vertebra 118, the surgeon should be able to sense the reducedresistance and friction on the tool. Furthermore, the tool may beprovided with stops or a drill bit may be cannulated to preventextension of the drill beyond the anterior side 124 of the vertebra 118.

In the present configuration right side 126 placement of the firstpedicle screw 12 is preferable to avoid soft tissue injuries to thepatient's anterior caused by penetration of the drill bit through theanterior side 124 of the vertebra 118 via the passageway 110 of thefirst pedicle screw 12. Anatomically, fragile soft tissue and bloodvessels are positioned adjacent the right side 126 on the anterior side124 of the vertebra 118. By using any number of surgical retractiontechniques, these blood vessels may be held toward the right side 126 ofthe anterior side 124 of the vertebra 118. As such, the right side 126placement of the first pedicle screw 12 represents the most efficient,as well as safest, placement for utilizing the first pedicle screw 12 inaccordance with the present invention. In some instances, however, leftside 128 placement of the first pedicle screw 12 in the vertebra 118will be necessary. Left side 128 placement of the first pedicle screw 12will be discussed in greater detail with reference to FIG. 8.

FIG. 6 illustrates yet another aspect of the present invention of aguide member 150. The guide member 150 includes a coupling portion 152an offset member 154 and an alignment member 156. The coupling portion152 is operable to couple with the coupling portion 100 of the firstpedicle screw 12 (see FIG. 4). The offset member 154 is connected to thecoupling portion 152. The offset member 154 extends from the couplingportion 152 relative to the connection of the coupling portion 152 tothe coupling portion 100 of the first pedicle screw 12. The alignmentmember 156 is connected to the offset member 154. The alignment member156 is operable for alignment of the connecting screw, such as the firstconnecting screw 40, with a portion of the first pedicle screw 12, suchas the engaging portion 22.

The guide member 150 may be constructed from a variety of materials suchas, but not limited to, titanium, steel, metal or other metal alloys, asubstantially rigid polymeric material, aluminum or other substantiallyrigid materials sufficient for these purposes. The coupling portion 152is provided with a first end 160 and a second end 162. The first end 160of the coupling portion 152 may be threaded for threading engagement tothe coupling portion 100 of the first pedicle screw 12.

It should be appreciated, however, that a number of connecting methodsmay be utilized to accomplish the connection of the first end 160 of thecoupling portion 152 to the coupling portion 100 of the first pediclescrew 12. For example, the first end 160 may be shaped so as to besubstantially rectangular or other geometric shape about a portion ofthe first end 160 such that a similarly geometrically configured openingin the coupling portion 100 in the distal end 102 of the first pediclescrew 12 is adapted to receive the first end 160 of the coupling portion152. Other locking or tensioning engagements of the first end 160 of thecoupling portion 152 to the coupling portion 100 of the first pediclescrew 12, as well as a variety of other methods for achieving thisattachment, will readily suggest themselves to one of ordinary skill inthe art and are within the spirit and scope of the present invention.

The second end 162 of the coupling portion 152 is attached to the offsetmember 154. The attachment of the coupling portion 152 to the offsetmember 154 may be of a connecting, such as threading or tensioning orlocking connection, or may be accomplished by a welded or bondedconnection of the second end 162 of the coupling portion 152 to theoffset member 154. Although welding or bonding engagements of variouscomponents of the vertebral stabilization assembly 10 of the presentinvention are preferable, it should be appreciated that bonding or othergluing or tacking materials may be used for this connection andsatisfactory for these purposes.

The offset member 154 is shown as a substantially arcuate memberextending from the second end 162 of the coupling portion 152 to thealignment member 156. However, in other configurations, one of which isdescribed hereinafter, the alignment member 156 may be comprised of anumber of foldable or extendable or hinging segments to promote usewithin the confinements of the patient's anterior. While the offsetmember 154 is shown as a substantially rigid arcuate member, a number ofother configurations of the offset member 154, such as a substantiallystraight member, or a stair-stepped member, as well as the offset member154 being comprised of several connectable or extendable members arecontemplated according to other aspects (not shown) of the presentinvention.

A number of configurations of the offset member 154, such as formationof a portion of the offset member 154 unitarily with the couplingportion 152 and formation of a remaining portion of the offset member154 unitarily formed with the alignment member 156 may also be utilizedfor these purposes. Although the offset member 154 is shown in thepreferred aspect, a variety of configurations of the offset member 154will readily suggest themselves to one of ordinary skill in the art forpositioning the alignment member 156 relative to a portion of the firstpedicle screw 12 when the coupling portion 152 of the guide member 150is connected to the coupling portion 100 of the first pedicle screw 12and are within the spirit and scope of the present invention and willnot be discussed in further detail for the purposes of brevity.

The alignment member 156 is rigidly connected to the offset member 154by welding or bonding or other similar means. However, attachment of thealignment member 156 to the offset member 154 may be accomplished by athreading, locking or tensioning engagement and is satisfactory forthese purposes. The alignment member 156 is a substantially tubularmember having a first end 164 and a second end 166 and an opening 168extending through from the first end 164 to the second end 166.

The alignment member 156 is provided such that the opening 168 is of asufficient diameter to receive a drilling device 170, shown in phantom,through the opening 168 for alignment with the engaging portion 22 onthe shaft 16 of the first pedicle screw 12. The drilling device 170 maybe a bit of a drill or other devices operative to drill an opening intovertebral bone. Thus, the alignment member 156 receives the drillingdevice 170 that drills an opening properly aligned for attachment of thefirst connecting screw 40 to the first pedicle screw 12. Thus, the guidemember 150 is advantageously provided for creating an opening alignedwith the engaging portion 22 of the first pedicle screw 12.

It should be appreciated that while the alignment member 156 of thepresent aspect is illustrated as a substantially tubular member havingan opening 168, other configurations of the alignment member 156 may notbe a completely tubular, and instead, be provided as a guide orpositioning member for alignment of the first connecting screw 40 withthe engaging portion 22 of the first pedicle screw 12.

Numerous configurations for aligning the first connecting screw 40 withthe engaging portion 22 of the first pedicle screw 12 may be utilizedfor these purposes and will readily suggest themselves to one ofordinary skill in the art and are within the spirit and scope of thepresent invention and will not be discussed further for purposes ofbrevity.

FIG. 7 illustrates a top view of the vertebra 118 shown with the firstpedicle screw 12 positioned therein with the guide member 150 shownattached to the first pedicle screw 12. In this view, it can be seenthat the guide member 150 is a useful tool for placement of the firstconnecting screw 40 for attachment to the engaging portion 22 of thefirst pedicle screw 12. It will be appreciated that, procedurally, thefirst pedicle screw 12 has been percutaneously placed through theposterior side 122 of the vertebra 118. Thereafter the tool, such as thedrill, as previously discussed, is caused to drill through the anteriorside 124 of the vertebra 118 thus locating the position of the couplingportion 100 on the distal end 102 of the first pedicle screw 12.

At this point, the guide member 150 may be positioned such that thecoupling portion 152 extends through the drilled opening on the anteriorside 124 of the vertebra 118. The coupling portion 152 of the guidemember 150 is then connected to the coupling portion 100 of the firstpedicle screw 12. An innovative aspect of the pedicle screw 12 is thatthe coupling portion 100 on the distal end 102 of the first pediclescrew 12 is associated with the engaging portion 22 on the shaft 16 ofthe first pedicle screw 12. The association of the coupling portion 100and engaging portion 22 of the first pedicle screw 12 is a significantadvantage of the first pedicle screw 12 according to the presentinvention. That is, this association allows for the guide member 150 tobe configured relative to this association. Thus, the coupling portion152 of the guide member 150, when coupled to the first pedicle screw 12,aligns the alignment member 156 with the engaging portion 22 on theshaft 16 of the first pedicle screw 12. Utilizing the guide member 150,several methods exist for aligning and securing the first connectingscrew 40 to the first pedicle screw 12. It may be preferable to utilizethe drilling device 170 to create an opening in the anterior side 124 ofthe vertebra 118. Thereafter, the guide member 150 may be removed andthe first connecting screw 40 disposed through the opening drilled inthe vertebra 118 and connected to the first pedicle screw 12.

In some instances, it may be beneficial for the alignment member 156 tobe adapted to receive the first connecting screw 40 positioned to extendthrough the opening 168 of the alignment member 156. The firstconnecting screw 40 may then be drilled or threaded directly into theleft side 128 of the anterior side 124 of the vertebra 118. Whether anopening is first drilled or the first connecting screw 40 is directlydrilled into the vertebra 118, the unique configuration of the guidemember 150 relative to the first pedicle screw 12 insures that the firstconnecting screw 40 will be properly aligned so as to locate theengaging portion 22 of the first pedicle screw 12 for engagingattachment thereto.

Thus, another advantage of the guide member 150 of the present inventionis that the coupling portion 152 of the guide member 150 is operable tocouple with the coupling portion 100 of the first pedicle screw 12 suchthat the offset member 154 extends in a predetermined direction relativeto the coupling of the coupling portion 152 of the guide member 150 tothe coupling portion 100 of the first pedicle screw 12. The offsetmember 154 of the guide member 150 is positionable relative to thecoupling of the coupling portion 152 of the guide member 150 with thecoupling portion 100 of the first pedicle screw 12.

It will be appreciated that the connection of the coupling portion 152of the guide member 150 to the coupling portion 100 of the first pediclescrew 12 must be a locking or fitted type connection such that theoffset member 154 properly extends in the proper direction to positionthe alignment member 156 for alignment with the engaging portion 22 ofthe first pedicle screw 12. Achieving the accuracy necessary to locatethe engaging portion 22 of the first pedicle screw 12, which will not bevisible since the first pedicle screw 12 will be embedded within thevertebra 118, is preferably accomplished through the accurate couplingconnection of the coupling portion 152 of the guide member 150 to thecoupling portion 100 of the first pedicle screw 12.

It should be understood, however, that a number of other methods oflocating the engaging portion 22 of the first pedicle screw 12 foralignment with the first connecting screw 40 may be utilized. Forexample, providing indicia or markings on the head 60 of the firstpedicle screw 12 indicating the relative position of the engagingportion 22 of the first pedicle screw 12. The coupling portion 152 mayfurther include an extension (not shown) extendable through thepassageway 110 of the shaft 16 of the first pedicle screw 12. Theextension of the coupling portion 152 of the guide member 150 similarlyprovided with indicia, markings, or an alignment with the indiciaprovided on the head 60 of the first pedicle screw 12. In this manner,when the indicia are aligned, so is the alignment member 156 alignedwith the engaging portion 22 on the first pedicle screw 12.

A variety of other methods for obtaining this positioning and alignmentfor connecting the first connecting screw 40 to the first pedicle screw12 will readily suggest themselves to one of ordinary skill in the artand are within the spirit and scope of the present invention and willnot be discussed for purposes of brevity.

FIG. 8 illustrates an alternative left side 128 placement of the firstpedicle screw 12 in the vertebra 118. Procedurally, numerous methods maybe utilized to determine whether the first pedicle screw 12 issatisfactorily stabilized within the vertebra 118, including electricalstimulation to test for a desired threshold. In certain circumstances,such as when the right side 126 placement of the first pedicle screw 12is ineffective to achieve the desired or required stability, left side128 placement of the first pedicle screw 12 may be necessary. In thisinstance, the present invention may be utilized in substantially thesame manner for left side 128 placement.

The significant difference between the first pedicle screw 12 utilizedfor right side 126 placement, as opposed to left side 128 placement, isan angle 176 of the engaging portion 22 of the first pedicle screw 12relative to an axis extending centrally through the shaft 16, such asthe passageway 110 of the first pedicle screw 12. It can be seen thatthe angle 176 of the engaging portion 22 of the first pedicle screw 12necessary for placement of the first connecting screw 40 about the leftside 128 of the anterior side 124 of the vertebra 118 variesconsiderably depending upon whether the first pedicle screw 12 isconnected from the left side 128 or the right side 126 of the vertebra118. For this reason, a unique first pedicle screw 12 and guide member150 will be constructed for the left side 128 versus right side 126placement, such that the guide member 150, when connected to the firstpedicle screw 12, properly aligns the first connecting screw 40 basedupon which vertebral placement, and corresponding first pedicle screw 12is utilized.

FIG. 9 illustrates another aspect of the first pedicle screw 12 as wellas another aspect of the guide member 150. The vertebra 118 is shownhaving a midline 178 extending from the anterior side 124 to theposterior side 122 of the vertebra 118. The coupling portion 152 of theguide member 150 is shown connected to the first pedicle screw 12 on theleft side 128 of the vertebra 118 adjacent the midline 178. Aspreviously discussed, placement of the first pedicle screw 12 on theleft 128 anterior side 124 of the vertebra 118 may be preferable.

In this aspect the guide member 150 is shown having a substantiallynon-arcuate offset member 154 such that the alignment member 156 extendsangularly from the offset member 154. The coupling portion 152 is shownas a substantially tubular member having a channel 180 extending throughthe coupling portion 152. The coupling portion 152 is provided with arecess 182 extending into the channel 180 near the first end 160 of thecoupling portion 152. Furthermore, in this aspect, the first end 160 ofthe coupling portion 152 is adapted to matingly receive the firstpedicle screw 12 near the distal end 102 thereof. As previouslydiscussed, the first pedicle screw 12 is provided with a couplingportion 100 provided, in this aspect, as an opening in the distal end102 of the first pedicle screw 12.

A locking screw 184 may be extended through the channel 180 from thesecond end 162 toward the first end 160 of the coupling portion 152. Thelocking screw 184 is provided with a head 186 having a larger diameterthan that of a shaft 188 portion of the locking screw 184. The first end160 of the coupling portion 152 is matingly connectable to the distalend 102 of the first pedicle screw 12. The locking screw 184 ispositioned through the channel 180 until the shaft 188 portion of thelocking screw 184 couples with the coupling portion 100 of the firstpedicle screw 12.

A tool (not shown) having any standard screw driver or hex,octagonal-type or other connection, for example, may be extended downthe channel 180 and used to connect the locking screw 184 to thecoupling portion 100 of the first pedicle screw 12. The locking screw184 may be threadingly screwed into engagement with the first pediclescrew 12 or connected in other manners which are well known and willreadily suggest themselves to one of ordinary skill in the art.

In this manner, the head 186 of the locking screw 184 engages the recess182 within the channel 180 of the coupling portion 152 thereby engagingthe coupling portion 152 to the first pedicle screw 12. It will beappreciated that the locking screw 184, the coupling portion 152 and theguide member 150 may be provided with indicia or markings to indicatelocking engagement and alignment with both the first pedicle screw 12and the vertebra 118 since it is critical that the locking screw 184couple the coupling portion 152 to the first pedicle screw 12 at aparticular position relative to the vertebra 118. The indicia ormarkings may include cross-hair lines, a single line or mark, an arrow,or other markings indicating a rotational position desired for achievingthis connection and location.

Such accurate positioning may be accomplished based on the threads ofthe shaft 188 of the locking screw 184 corresponding to threadedopenings within the coupling portion 100 of the first pedicle screw 12.A variety of different structural attachments for obtaining this lockingconnection for alignment of the guide member 150 with the first pediclescrew 12 such that the alignment member 156 is substantially alignedwith the engaging portion 22 on the shaft 16 of the first pedicle screw12 may be utilized and are within the spirit and scope of the presentinvention and will readily suggest themselves to one of ordinary skillin the art.

FIG. 10 illustrates the first pedicle screw 12 placed from the rightside 126 on the posterior side 122 of the vertebra 118. It will beappreciated that the exact placement and size of the first pedicle screw12 relative to the vertebra 118, as shown and disclosed, herein may beenlarged or reduced proportionately depending upon the characteristicsof the vertebra 118 and the goals of the vertebral stabilizationassembly 10. However, the first pedicle screw 12 is preferably securedin the pedicle portion of the vertebra 118 such that the distal end 102of the first pedicle screw 12 is coupleable to the guide member 150 onthe left side 128 on the anterior side 124 adjacent the midline 178 ofthe vertebra 118.

In some aspects, the guide member 150 may be provided with a rotationalcoupling 190 such as a recess or opening in the offset member 154 of theguide member 150. The rotational coupling 190 may be adapted as anopening to receive a tool or device for obtaining leverage on the guidemember 150 for rotation of the guide member 150. It will be appreciatedthat while the first pedicle screw 12 may be provided with indicia orother markings on the head 60 of the first pedicle screw 12 fordetermining the location and disposition of the engaging portion 22 ofthe first pedicle screw 12, a surgeon may have difficulty determiningfrom the posterior side 122 of the vertebra 118 the optimum location forplacement of the connecting screw, such as the first connecting screw40.

Once the patient has been rotated and the guide member 150 connected tothe first pedicle screw 12 on the anterior side 124 of the vertebra 118,only then will the surgeon be able to determine the preferable placementof the first connecting screw 40 relative to the body of the vertebra118. In the event the first pedicle screw 12 is not aligned preferablyfor the first connecting screw 40, by use of the rotational coupling190, such as with a tool connected thereto, the surgeon may rotate theguide member 150 and the first pedicle screw 12 rigidly connectedthereto, via the locking screw 184, to obtain the optimum placement ofthe first connecting screw 40 into a desired point in the body of thevertebra 118. In other configurations, the guide member 150 may notinclude the rotational coupling 190 and, as such, this rotationalalignment may be achieved by grasping and rotating the offset member 154or other portions of the guide member 150.

Once this optimum positioning has been obtained by rotation using therotational coupling 190 the tool coupled to the rotational coupling 190may be removed and a drill or other tool may be utilized and aligned viathe alignment member 156 for drilling an opening into the body of thevertebra 118 at the desired location. Thereafter, the locking screw 184and a guide member 150 may be removed for connection of the firstconnecting screw 40 to the engaging portion 22 of the first pediclescrew 12.

It will be appreciated that the locking screw 184 may be connected in avariety of manners to the coupling portion 152 of the guide member 150to obtain a corresponding rotation of the guide member 150 with thefirst pedicle screw 12 for these rotational purposes which will readilysuggest themselves to one of ordinary skill in the art and are withinthe spirit and scope of the present invention.

FIG. 11 illustrates another aspect of the connection of the firstpedicle screw 12 to the coupling portion 152 of the guide member 150. Aspreviously discussed above, a variety of methods exist for connectingthe coupling portion 152 with the coupling portion 100 of the firstpedicle screw 12. In the present aspect illustrated in FIG. 11, thecoupling portion 100 of the first pedicle screw 12 is a substantiallyrectangular member extending from the shaft 16 of the first pediclescrew 12.

The coupling portion 152 of the guide member 150, in the present aspect,is provided with a substantially rectangular opening 196 in the firstend 160 of the coupling portion 152. The substantially rectangularopening 196 is sized to matingly receive the rectangular couplingportion 100 to achieve a fitted coupling there between. In this aspect,the coupling portion 100 may be provided with a threaded opening 198 onthe distal end 102 of the first pedicle screw 12. In this manner, thechannel 180 extending through the coupling portion 152 may be providedto guide a connecting member, such as the locking screw 184 or otherengaging structure, to be threadingly received by the threaded opening198 in the distal end 102 of the first pedicle screw 12.

In this manner, the combination of the locking mechanism, such as thelocking screw 184, as well as the rectangular configuration of thecoupling portion 100 of the first pedicle screw 12 with thesubstantially rectangular opening 196 in the first end 160 of thecoupling portion 152 promotes an accurately engaged connection of theguide member 150 with the first pedicle screw 12. It should beappreciated that in other aspects the threaded opening 198 and thechannel 180 may be eliminated and only the mating connection of therectangular coupling portion 100 of the first pedicle screw 12 with thesubstantially rectangular opening 196 of the coupling portion 152 willbe sufficient for this connection.

It will be appreciated that the configuration illustrated in the currentaspect promotes a sufficient engagement of the guide member 150 to thefirst pedicle screw 12 to achieve engaging rotation of the first pediclescrew 12 by the guide member 150 when such adjustment for alignmentpurposes of the first pedicle screw 12 is desirous. It should beappreciated that while the coupling portion 100 of the current aspect isshown as substantially rectangular in configuration as is thesubstantially rectangular opening 196 of the coupling portion 152 of theguide member 150, a variety of other configurations such as, but notlimited to, triangular configurations, will readily suggest themselvesto one of ordinary skill in the art and are within the spirit and scopeof the present invention, as are a variety of other coupling connectionsbetween the coupling portion 152 and the first pedicle screw 12 whichmay be utilized to achieve these purposes.

FIG. 12 is a flow chart illustrating a method 200 for stabilizing anupper and lower vertebra 118A and 118B, substantially similar to thevertebra 118 illustrated in FIGS. 5 and 7, from an anterior side 124 ofthe vertebra 118A and 118B using the vertebral stabilization assembly 10in accordance with the present invention. The method includes, at ablock 202, inserting the first pedicle screw 12 into the lower vertebra118B through the pedicle 120 and into the body of the lower vertebra118B from a posterior side 122 of the lower vertebra 118B. The firstpedicle screw, as previously described above, includes the shaft 16provided with the threaded portion 18 operable to threadingly engage thelower vertebra 118B. The shaft 16 of the first pedicle screw 12 isprovided with the engaging portion 22 that is operable to receive thefirst connecting screw 40. The shaft 16 of the first pedicle screw 12further has the coupling portion 100 that is operable to couple with theguide member 150.

The method further includes, at a block 204, inserting a second pediclescrew 14 into the upper vertebra 118A through the pedicle 120 andvertebral body of the upper vertebra 118A from the posterior side 122 ofthe upper vertebra 118A. The second pedicle screw 14 including the shaft30 provided with the threaded portion 32 operable to threadingly engagethe upper vertebra 118A. The shaft 30 of the second pedicle screw 14provided with an engaging portion 36 operable to receive the secondconnecting screw 42. The shaft 30 of the second pedicle screw 14 havinga coupling portion 100, substantially similar to the coupling portion100 of the first pedicle screw 12, to couple with the guide member 150.

The first and second pedicle screws 12 and 14 are preferably placed onthe posterior side 122 on the right side 126 of the upper and lowervertebra 118A and 118B, respectively. It will be appreciated that in oneaspect the present invention may be utilized preferably with respect tothe lumbar vertebra, while in other configurations the present inventionmay be preferably utilized with regard to the thoracic vertebra.

At a block 206, the method includes locating the coupling portion 100 ofthe shaft 16 of the first pedicle screw 12 from the anterior side 124 ofthe lower vertebra 118B. As previously discussed, in one aspect thepedicle screw 12 of the present invention may be provided with thecannulated shaft 16 having the passageway 110 extending through theshaft 16 of the first pedicle screw 12. In this aspect a tool, such as adrill operable to drill through a portion of the lower vertebra 118B,may be extended through the passageway 110 of the shaft 16 of the firstpedicle screw 12. The tool may be used to drill through a portion of thelower vertebra 118B such that the tool extends partially through theanterior side 124 at the lower vertebra 118B. Similarly, the secondpedicle screw 14 may be similarly provided with the passageway 110 forpassing the tool there through to drill through a portion of the uppervertebra 118A such that the drill extends at least partially through theanterior side 124 of the upper vertebra 118A.

At a block 208 the method includes coupling the guide member 150 to thecoupling portion 100 of the shaft 16 of the first pedicle screw 12 fromthe anterior side 124 of the lower vertebra 118B. In one aspect thecoupling of the guide member may be more readily accomplished after anopening has been drilled through to the anterior side 124 of the lowervertebra 118B. The method further includes, at a block 210, insertingthe lower connecting screw, such as the first connecting screw 40,through the anterior side 124 of the lower vertebra 118B using the guidemember 150. As previously discussed, the guide member is a useful toolfor aligning the alignment member 156 of the guide member 150 andcorrespondingly the first connecting screw 40 with the engaging portion22 of the first pedicle screw 12.

The method further provides, at a block 212, locating the couplingportion 100 of the shaft 30 of the second pedicle screw 14 from theanterior side 124 of the upper vertebra 118A. The method furtherprovides, at a block 214, for coupling the guide member 150 to thecoupling portion 100 of the shaft 30 of the second pedicle screw 16 fromthe anterior side 124 of the upper vertebra 118A.

At a block 216, the method includes inserting an upper connecting screw,such as the second connecting screw 42 through the anterior side 124 ofthe upper vertebra 118A utilizing the guide member 150 for properalignment. The method also provides, at a block 218, for connecting theupper and lower connecting screws, such as the first and secondconnecting screws 40 and 42, to the connecting member 50 forstabilization of the upper and lower vertebra 118A and 118B.

FIG. 13 illustrates another aspect of the first pedicle screw 12 havinga reinforced portion 230 provided on the shaft 16. The reinforcedportion 230 of the shaft 16 provides additional structural stability forconnection of the connecting screw, such as the first connecting screw40, to the engaging portion 22 to ensure a rigid and stable connectionof the first connecting screw 40 to the first pedicle screw 12. Thereinforced portion 230 is shown having a diameter 232 that is greaterthan a diameter 234 of a first threaded portion 236 of the shaft 16. Inthis manner, it is readily apparent that the reinforced portion 230having a greater diameter 232 will provide additional structuralstability and support for connection of the first connecting screw 40with respect to the smaller diameter 234 of the first threaded portion236 of the shaft 16. The first threaded portion 236 of the shaft 16 isprovided with a plurality of threads 238 connected to and extending fromthe shaft 16 of the first pedicle screw 12. It can be seen that thediameter 232 of the reinforced portion 230 is about equal to a diameter240 measured from an outermost edge of the plurality of threads 238 ofthe first threaded portion 236.

As the first pedicle screw 12 is threadingly engaged into the pedicleportion of the vertebra, such as the first vertebra 20, the firstthreaded portion 236 will threadingly engage and retain the firstpedicle screw 12 within the first vertebra 20. In the presentconfiguration the reinforced portion 230 is not provided with threads,however, in other configurations the reinforced portion may be providedwith threads similar to the plurality of threads 238 or threadsextending less far from the reinforced portion 230 than the plurality ofthreads 238 extend from the first threaded portion 236 of the shaft 16.In one aspect, the diameter 232 of the reinforced portion 230 is about6.5 millimeters. However, in other configurations the diameter 232 ofthe reinforced portion 230 may be greater or less than 6.5 millimetersas may be necessary to properly engage the shaft 16 of the first pediclescrew 12 in the first vertebra 20.

The shaft 16 of the first pedicle screw 12 is further provided with asecond threaded portion 242 having a plurality of threads 244 forengaging the first vertebra 20. In the present aspect, the diameter 232of the reinforced portion 230 is less than the diameter 246 measuredfrom an outermost edge of the plurality of threads 244 provided on thesecond threaded portion 242. As the first pedicle screw 12, of thepresent aspect, is engaged into the first vertebra 20, the firstthreaded portion 236 will threadingly engage the pedicle portion andthereafter an interior vertebral body portion of the first vertebra 20.As the reinforced portion 230 of the first pedicle screw 12 followsbehind the first threaded portion 236, the reinforced portion 230 mayhave the affect of smoothing the threading engagement within thevertebral body. For this reason, it may be advantageous to provide theplurality of threads 244 having a greater diameter 246 for providingadditional threading engagement of the first pedicle screw. In otheraspects (not shown) frictional engaging surface structure, such as smallor low profile threads, may be provided on the reinforced portion 230for frictionally engaging the inner vertebral body at the first vertebra20.

In the present aspect, the diameter 246 of the plurality of threads 244may be about 7.0 millimeters to achieve additional threading engagementof the second threaded portion 242 of the shaft 16 for stable engagementof the first pedicle screw 12 within the first vertebra 20. It will beappreciated, however, that in other aspects (not shown) the diameter 246of the plurality of threads 244 may be of larger or smaller diameter ormay be of a similar or smaller diameter than the diameter 232 of thereinforced portion 230 and be adequate for these purposes. Furthermore,in other aspects (not shown) the diameter 234 of the first threadedportion 236 of the shaft 16 may be the same or larger diameter than thatof the diameter 232 of the reinforced portion 230. The reinforcedportion 230 of the shaft 16 provides significant additional structuralstability for connection of the first connecting screw 40 to the firstpedicle screw 12 via the engaging portion 22. While the length of thereinforced portion 230 relative to the length of the entire shaft 16 ofthe first pedicle screw 12 is shown in relative proportion according tothe present aspect, the reinforced portion 230, according to otheraspects (not shown), may be of significantly greater length and diameteror having a smaller length and diameter relative to the shaft 16 of thefirst pedicle screw 12 and are within the spirit and scope of thepresent invention as disclosed and described herein.

FIG. 14 illustrates a perspective view of another aspect of the pediclescrew 12 wherein the shaft 16 is provided with at least a first groove250 extending a distance along the shaft 16 of the first pedicle screw12. In the present aspect, a plurality of grooves 250 are shown adjacenta plurality of raised threaded portions 252. The raised threadedportions 252 are provided for threadingly engaging the first vertebra 20for securing the first pedicle screw 12 to the first vertebra 20. Theone or more grooves 250 are provided for engaging the first pediclescrew 12 by a tool which will be discussed in greater detail hereinafterwith respect to FIGS. 17 and 18. In certain circumstances it may beuseful or necessary to rigidly retain the first pedicle screw 12 fromthe anterior side of the first vertebra 20, such as when connecting thefirst connecting screw 40 to the first pedicle screw 12. The one or moregrooves 250 provided on the shaft 16 promotes engagement of the firstpedicle screw 12 by a tool near the distal end 102 of the shaft 16.

FIG. 15 illustrates a cross section of the first pedicle screw 12illustrated in FIG. 14 taken along a line 15-15 thereof. In this view,the one or more grooves 250 provided on the shaft 16 of the firstpedicle screw 12 can be seen with respect to their relationship to theraised threaded portions 252. This configuration is useful for promotingengagement of a tool for connecting near the distal end 102 of the firstpedicle screw 12. Although the grooves 250 are shown as generallyrounded in configuration extending a distance along the length of theshaft 16 it will be appreciated that in other configurations (not shown)the grooves 250 may be angular, such as rectangular or triangular inconfiguration, and having a wider or narrower width 254 which are withinthe spirit and scope of the present invention as disclosed and describedherein.

In this view, it can be seen that a number of grooves 250 such as two orfour grooves 250 may promote improved engagement by a tool of the firstpedicle screw 12 near the distal end 102, however, any number of grooves250 may be utilized and are within the spirit and scope of the presentinvention.

It will be appreciated that the configuration of the first pedicle screw12 illustrated having one or more grooves 250 extending a distance alongthe length of the shaft 16 may also be utilized with respect to theconfiguration of the first and second connecting screws 40 and 42. Inthis manner, a tool may be utilized to connect to the second end 64 ofthe first connecting screw 40 for inserting the first connecting screw40 into the engaging portion 22 of the first pedicle screw 12, as wellas for removal of the first connecting screw 40 from the engagingportion 22 of the first pedicle screw 12.

From time to time it may be necessary to remove portions of thevertebral stabilization assembly 10 of the present invention from thepatient and it will become necessary for the first connecting screw 40and the first pedicle screw 12 to be configured so as to be easilyremovable. It will be appreciated that metal tightly connectedfrequently galls or becomes frozen. In this manner, configuration of thefirst pedicle screw 12 and the first connecting screw 40 having, forexample, grooves 250 and other similar configurations, as previouslydiscussed, and utilization of a tool adapted to engage the grooves 250along the shaft 16 of the first pedicle screw 12, for example, will bebeneficial for obtaining the necessary leverage for installation andremoval purposes.

FIG. 16 illustrates a cap 260 configured to be connected near the distalend 102 of the first pedicle screw 12. The cap 260 may be constructedfrom a variety of materials, such as a rigid or non-rigid plastic orpolymeric material, metallic or other materials adapted for connectionto the first pedicle screw 12 for penetration through the body of thefirst vertebra 20. In the present aspect it can be seen that the firstend 262 of the cap 260 is substantially conically shaped for promotingpenetration of the first pedicle screw 12 through the first vertebra 20.The cap 260 is advantageously provided where the first pedicle screw 12is provided with a flat surface 264 on the distal end 102 of the firstpedicle screw 12 (see FIG. 14).

A flat surface 264 on the distal end 102 of the first pedicle screw 12further promotes connection and engagement of a tool to the firstpedicle screw 12 for purposes which will be discussed hereinafter. Inthis aspect, the cap 260 will be necessary to reduce or minimize anydamage or aggravation caused by placement of the pedicle screw to anynerves or tissue in or about the area of the first vertebra 20, such asnerves positioned near the pedicle portion of the first vertebra 20.

The cap 260 is shown as a substantially conical member having an innersurface 266 that is provided with one or more notches 268 provided onthe inner surface 266 of the cap 260. The notches 268 are configured tobe tensioningly received by a recess 270 which may be provided on theshaft 16 of the first pedicle screw 12 as shown in FIG. 14. In thismanner, the notches 268 are tensioningly received by one or morerecesses 270 on the shaft 16 which retains the cap 260 sufficientlyengaged near the distal end 102 of the first pedicle screw 12, as wellas promoting easy removal of the cap 260 from the first pedicle screw12. The cap 260 may then be easily removed after placement of the firstpedicle screw 12 for attachment of the guide member 150, as well as atool for retaining and stabilizing the first pedicle screw 12 near thedistal end 102 of the first pedicle screw 12.

FIG. 17 illustrates a tool 280 constructed in accordance with one aspectof the present invention for stabilization of the first pedicle screw 12and the connecting screws, such as the first connecting screw 40. Thetool 280 is provided with a first end 282 having a handle 284 adapted tobe grasped by the hand of an individual. The tool 280 is provided with ashaft 286 extending from the first end to a second end 288. The shaft286 may be of sufficient length to easily utilize the tool 280 forconnection and removal of the vertebral stabilization assembly 10 duringthe surgical process.

A connector 290 is provided on the second end 288 of the tool 280 andconfigured so as to receive, for example, the shaft 16 of the firstpedicle screw 12 provided with one or more grooves 250 on the shaft 16.In this manner, the connector 290 is provided with mating notches 292adapted to be received by the grooves 250 on the shaft 16 of the firstpedicle screw 12.

Once positioned near the distal end 102 of the first pedicle screw 12,the mating notches 292 will receive and engage the first pedicle screw12 so that the tool 280, when rotated by the individual, will have theaffect of rotating the first pedicle screw 12, or, as previouslydiscussed, for stabilizing and retaining the first pedicle screw 12while removing or installing the connecting screws, such as the firstconnecting screw 40. As previously discussed, it may be necessary toutilize the tool 280 to stabilize the first pedicle screw 12,particularly when attempting to remove the rigid connection of the firstconnecting screw 40.

During the removal of the vertebral stabilization assembly 10, the firstconnecting screw 40 will likely be rigidly engaged in the engagingportion 22 of the first pedicle screw 12. When utilizing a first tool,such as the tool 280, to connect to for removal of the first connectingscrew 40, it may be necessary to utilize a second tool, such as the tool280, to engage the distal end 102 of the first pedicle screw 12 toretain the first pedicle screw 12 while removing the first connectingscrew 40. Utilization of one or more of the tools 280 may be beneficialwhile installing, as well as removing the vertebral stabilizationassembly 10.

Furthermore, it will be appreciated that in other aspects the connector290 may be provided on an electric or pneumatic device such as a drillor other apparatus.

FIG. 18 illustrates another aspect of the tool 280 and a differentaspect of the handle 284 as well as the connector 290. In this view, thehandle 284 is more easily grasped by a single hand, such as the handleof a common screw driver, and the connector 290 is configured with aplurality of flat surfaces 294, such as ordinarily found in an Allenwrench. In this manner, the first connecting screw 40 may be providedwith an opening 296 configured to receive the connector 290 forengagement of the tool 280 with the first connecting screw 40.

A number of configurations of the opening 296 on the second end 64 maybe utilized such as one or more grooves 250, and may be provided withassociated tools, such as the tool 280 to establish a rigid engagementof the tool 280 to the connecting screw, such as the first connectingscrew 40, and the first pedicle screw 12. It is within the scope of thepresent invention that the various configurations of the first pediclescrew 12 and the first connecting screw 40 may be interchanged alongwith the configurations of the tool 280 to promote maximum utility forinstallation and removal of the vertebral stabilization assembly. Forexample, the grooves 250 may be provided on the shaft 16 of the firstpedicle screw 12, substantially as shown with respect to FIGS. 14 and15, while the first connecting screw 40 may be provided with an Allenwrench type opening 296 or vice versa.

In this manner, one or more configurations of tools may be utilized onone or more of the elements of the vertebral stabilization assembly 10and are within the spirit and scope of the present invention asdisclosed and described herein. Furthermore, it will be appreciated thatthe opening 296 provided on the first connecting screw 40 or on thedistal end 102 of the first pedicle screw 12 may be tapped and threadedopening in a standard or reverse threaded manner for engagement of, forexample, the connector 290 having a threaded connector 290 (not shown)for engagement of the tool 280 to the first connecting screw 40 or thefirst pedicle screw 12.

Also, for example, where the distal end 102 of the first pedicle screw12 is substantially rectangularly shaped, such as in the aspectillustrated in FIG. 11, the connector 290 of the tool 280 may beconfigured to receive the rectangular distal end 102 of the firstpedicle screw 12 or a rectangularly shaped second end 64 of the firstconnecting screw 40. Many other configurations of the distal end 102 ofthe pedicle screw, such as the first pedicle screw 12, and connectingscrews, such as the first connecting screw 40, may be provided andassociated tools 280 having connectors 290 for connection thereto andwill readily suggest themselves to one of ordinary skill in the art andare within the spirit and scope of the present invention described anddisclosed herein.

Furthermore, it is within the spirit and scope of the present inventionthat the first connecting screw 40 may be provided with a double-boltedconfiguration on the threaded portion 66 of the first connecting screw40 and the connector 290 may be a socket-type connection to receive thebolt or bolts for removal of the first connecting screw 40 utilizing thetool 280.

FIG. 19 illustrates a bore screw 300 which may be utilized according toone aspect of the present invention. The bore screw 300 may be providedwith threads (not shown) and may be placed obliquely from the posteriorside 122 of the vertebra 118. The bore screw 300 may be sized such thatthe diameter 302 of the bore screw 300 is sized substantially similar toor smaller than the diameter of the pedicle screw, such as the firstpedicle screw 12. However, it will be appreciated that in other aspectsit may be advantageous for the diameter 302 of the bore screw 300 to besubstantially similar in size to that of the first pedicle screw 12 or,in some instances, for the diameter 302 to be substantially larger.

The bore screw 300 is shown disposed in the pedicle 120 at a desirableangle extending through the vertebra 118. In this manner the bore screw300 may be utilized to create a bore opening (not shown) that may beuseful for placing the pedicle screw, such as the first pedicle screw12, for placement of the pedicle screw from the anterior side 124 of thevertebra 118. In such a procedure the bore screw 300 may bepercutaneously placed in the posterior 122 of the vertebra 118.Thereafter the patient may be rotated such that the anterior 124 of thevertebra 118 is exposed. The bore screw 300 may be provided with acoupling portion 308 adapted for attachment by a tool (not shown) forremoval of the bore screw 300 through the anterior 124 side of thevertebra 118.

In other aspects, the bore screw 300 may be utilized from the anterior124 for tapping the vertebra 118. In other aspects, the coupling portion308 is adapted to engage the guide member 150 for determining alignment.For example, the guide member 150 may be attached to the couplingportion 308 of the bore screw 300 to determine the approximate locationof the connecting screw, such as the first connecting screw 40, andwhere the second end 64 of the first connecting screw 40 will be exposedon the anterior 124 side of vertebra 118.

Attachment of the guide member 150 to the bore screw 300 providesanother advantage of the present aspect in that it may be easilydetermined whether the bore screw 300 is placed at the appropriatelocation in the vertebra 118 or whether another placement will benecessary. This eliminates the need to place the pedicle screw, such asthe first pedicle screw 12, and then determine whether the placement isacceptable.

FIG. 20 illustrates a bore opening 310 which may have been created bythe bore screw 300, or in other configurations may have been created bya drill or other device capable of creating an opening in the vertebra118. An indicator 312 is shown disposed in the bore opening 310. Theindicator is provided with a shaft 314 and a light 316 provided on oneend of the shaft 314. The light 316 may be a common LED (light emittingdiode) or other light-emitting device which is suitable for thesepurposes, and may include laser light or laser light-emitting diodes.

The shaft 314 may be a substantially rigid shaft of sufficient length toextend down the length of the bore opening 310 and be operable to retainthe light 316 and communicate sufficient electrical power to maintainthe light 316 with power for driving the light 316. In other aspects,the shaft 314 may be a substantially flexible material such as wire orother flexible cording or material.

The indicator 312 is a useful device for indicating the location of thebore opening 310 from the anterior side 124 of the vertebra 118. Aspreviously discussed, a number of soft tissues exist on the right side126 on the anterior side 124 of the vertebra 118. For this reason,whether a bore screw 300 or a drill is utilized to create the boreopening 310 from the posterior side 122, it will be necessary in manycases to prevent penetration of the bore screw 300 or drill completelythrough the vertebra 118 on the anterior side 124 to prevent damage tothe soft tissues on the anterior side 124. The indicator 312 provides anopportunity once the patient has been rotated to retract the softtissues and identify the location of the bore opening 310 from theanterior side 124.

For example, the light 316 shown in the bore opening 310 will beperceptible by the surgeon from the anterior side 124 of the vertebra118. The surgeon may then drill from the anterior side 124 to completethe bore opening 310. Where the bore screw 300 is utilized, the borescrew may be provided with a light, such as the light 316, provided onthe distal end of the bore screw 300 and will be sufficient for thesepurposes. Once the light 316, whether provided on the indicator 312 orthe bore screw 300, has been identified and the bore opening has beendrilled to communicate with the anterior side 124 of the vertebra 118,the indicator 312 or bore screw 300 may then be removed from theanterior side. The indicator 314, such as when the light 316 is a highintensity LED or laser light, may be disposed near the posterior side122 or only slightly within the bore opening 310 such that the lightproduced by the light 316 projects down through the bore opening 310 andis sufficient to identify the bore opening 310 from the anterior side124 of the vertebra 118.

Furthermore, the indicator 312 may, in other aspects, be provided with apneumatic or hydraulically operated capability for punching or extendingthrough the anterior side 124 of the vertebra 118 when the indicator 312is extended through the bore opening 310, such as by utilizing a drill.In this manner, the indicator 312 may be left in place in the boreopening 310 and after the patient has been rotated such that theanterior side 124 of the vertebra 118 has been exposed, the pneumatic orhydraulically-operated indicator 312 may be activated so as to extendthrough the anterior side 124 for communication into the bore opening310.

The indicator 312 may be pulled through the anterior side 124 of thevertebra 118, and in instances where the shaft 314 is a flexiblematerial, it may be severed from, for example, behind the patient, foreasy removal through the anterior side. 124. Where the bore screw 300 isutilized and still in place, a tool (not shown) may be connected to thecoupling portion 308 of the bore screw 300 so that the bore screw 300may be removed through the anterior side 124 of the vertebra 118. Thisis advantageous since it eliminates the rotation of the patient forremoval of the bore screw 300 or the indicator 312. The elimination of arotational procedure further reduces the time of the overall procedureand is another advantage of the present aspect of the vertebralstabilization assembly 10 invention disclosed herein.

FIG. 21 illustrates another aspect of the vertebral stabilizationassembly 10 of the present invention. In this aspect the pedicle screw,such as the first pedicle screw 12, is placed in the vertebra 118 fromthe anterior side 124. By utilizing the bore opening 310, the pediclescrew 12 may be more easily and accurately placed into the vertebra 118from the anterior side 124. Placement of the first pedicle screw 12 fromthe anterior side 124 has a number of advantages including that theangle of placement has been previously defined by the bore opening 310.This allows for selection of the first pedicle screw 12 having anengaging portion 22 provided with the appropriate angle 320 with respectto connection of the connecting screw, such as the first connectingscrew 40 (shown in phantom).

It will be appreciated that the exact angle of placement of the firstpedicle screw 12 and resulting angle 320 with respect to the engagingportion 22 and first connecting screw 40 will be unknown until such timethat the first pedicle screw 12 is actually in place in the vertebra118. By previously providing the bore opening 310, the proper pediclescrew may be selected based upon the desired resulting angle 320 soughtfor the resulting placement of the first connecting screw 40. That is,it may be advantageous in certain instances to provide the second end 64of the first connecting screw 40 at a specific location on the left side128 on the anterior side 124 of the vertebra 118. Unless the firstpedicle screw 12 is exactly placed, the resulting location of the secondend 64 of the first connecting screw 40 may be significantly differentthan that desired. For this reason, a number of pedicle screws may beadvantageously provided to the surgeon each having a different lengthand a different engaging portion 22 with respect to the angle ofconnection of the first connecting screw 40 to the engaging portion 22.By having a number of choices available to the surgeon, and based uponthe angle of the bore opening 310, the first pedicle screw 12 may beselected as having an engaging portion 22 that will provide the angle320 that will result in the second end 64 of the first connecting screw40 being positioned at the desired location on the anterior side 124 ofthe vertebra 118.

Anterior side 124 placement of the first pedicle screw 12 within thevertebra 118 provides numerous additional advantages including thedimensions of the first pedicle screw 12 and resulting stability thatmay be achieved from such placement. For example, the first pediclescrew 12, such as that illustrated in FIGS. 4 and 13, may be readilyutilized for these purposes, and may achieve advantageous stabilizationby being placed from the anterior 124 side of the vertebra 118. Forexample, with respect to the first pedicle screw 12 illustrated in FIG.13, it can be seen that the diameter 232 of the reinforced portion 230is slightly smaller than the diameter 246 of the plurality of threads244 according to one aspect.

Since the reinforced portion 230 will not obtain the threadingengagement, it is necessary for the plurality of threads 244 of thefirst pedicle screw 12 to be slightly larger to achieve a satisfactoryanchoring and threading engagement of the first pedicle screw 12.Otherwise, the reinforced portion 230 might have the affect of smoothingthe opening such that the plurality of threads 244 do not successfullyengage within the vertebra 118.

Conversely, anterior side 124 placement of the pedicle screw allows forthe plurality of threads 238 near the distal end 102 of the firstpedicle screw 12 to be of a maximum diameter 240 for optimum anchoringand stabilization of the pedicle screw within the vertebra 118 andparticularly within the pedicle portion 120. At the same time, thediameter 232 of the reinforced portion 230 may be of a maximum diameterfor reinforcement to optimize the connection and engagement of the firstconnecting screw 40 and such structure will not reduce or minimize theengagement of the first pedicle screw 12 with the vertebra 118. Thereason for this is that the plurality of threads 238 will be in front ofthe reinforced portion 230 when anteriorly placed versus behind thereinforced portion 230, as is the case with the plurality of threads 244when the pedicle screw 12 is posteriorly placed. In one aspect, diameter232 of the reinforced portion 230 is similarly sized relative to thediameter 246 of the plurality of threads 244 or any other threadsprovided on the shaft 16. However, numerous configurations of shaft 16sized and thread sizes will readily suggest themselves to one ofordinary skill in the art and are within the spirit and scope of thepresent invention.

It should be appreciated that a variety of configurations of pediclescrews have been disclosed and shown herein and any of the variousconfigurations may be utilized both for posterior placement of the firstpedicle screw 12 as well as for anterior placement of the first pediclescrew 12. Furthermore, it will be appreciated that a number of tools,such as the tool 280 illustrated in FIGS. 17 and 18, have been shown anddescribed and may be readily implemented on the first pedicle screw 12for anterior placement.

FIG. 22 illustrates the first pedicle screw 12 connecting to the guidemember 150 for proper alignment of the connecting screw, such as thefirst connecting screw 40 to the first pedicle screw 12. In one aspect,the present invention is directed to the vertebra stabilization assembly10 wherein the complete procedure may be accomplished from the anteriorside 124 of the vertebra 118. The procedure for such placement mayinclude drilling a hole utilizing a drill or other device or implementthrough the outer surface of the anterior side 124 of the vertebra 118to penetrate the hard outer bone surface.

Thereafter utilizing technology typically employed for such purposes,such as an image intensifier, x-ray and templates, and/or other stealthtechnology, a K-wire or other drill or penetrating implement may beutilized to penetrate in a direction toward the posterior side 122 alonga line 326. The K-wire may be obliquely placed through the vertebralbody into the pedicle 120 on the right side 126. A cannulated drill maybe utilized to drill over the K-wire to ream out a hole or opening forplacement of the first pedicle screw 12 therein. The drill and K-wiremay be removed and the first pedicle screw 12 may be anteriorly placedin the drilled opening substantially along the line 326 for properplacement of the first pedicle screw 12 in the vertebra 118. Thisaspect, as previously discussed, advantageously provides for selecting,in advance, the proper pedicle screw, such as the first pedicle screw12, having the engaging portion 22 to achieve the desired angle ofconnection of the connecting screw, such as the first connecting screw40.

Another advantage of anterior placement of the first pedicle screw 12 isthat it provides the opportunity for stabilization from the posteriorside 122 when such may be desirable. In this aspect, the first pediclescrew 12, such as that illustrated and previously disclosed herein in anumber of different configurations, may be utilized by placementinitially from the anterior side 124 such that the distal end 102 isanchored substantially in the pedicle 120 portion of the vertebra 118.Thereafter, the first pedicle screw 12 may be utilized for connection ofconnecting members, such as the connecting member 50, for standardposterior anchoring and stabilization when such is necessary because ofa failure to achieve adequate stabilization from the anterior side 124as preferably provided herein.

Under the preferred anterior stabilization and when the first pediclescrew 12 is placed from the anterior side 124 of the vertebra 118, thefirst pedicle screw 12 is provided with a coupling portion 100 near thehead 60 of the first pedicle screw 12, substantially as shown in FIG.22.

Utilization of the vertebral stabilization assembly 10 according to theaspect illustrated in FIG. 22, has the additional advantage ofcompletely eliminating rotation of the patient during the procedure.However, it will be appreciated that there may be certain instances whenit is necessary or useful to rotate the patient for posterior access tothe vertebra 118 and such rotation will not reduce or detract from theadvantages of the vertebral stabilization assembly 10 of the presentinvention in that a significant portion or all of the procedure may beachieved from the anterior side 124 of the vertebra 118. This presents asignificant advantage in that rotation of the patient takes considerabletime and eliminating the necessity for such rotation shortens the timeperiod required for the procedure.

Once the first pedicle screw 12 has been placed on the anterior side 124of the vertebra 118 substantially as shown and discussed above withrespect to FIG. 22, the guide member 150 may be connected to the firstpedicle screw 12 at the coupling portion 100 in a manner similar to thatpreviously shown and described with respect to the coupling portion 100and a guide member 150. Utilization of the guide member 150 as well asthe connection of the connecting screws, such as the first and secondconnecting screws 40 and 42, as well as the bracket 50 remainssubstantially similar to that previously shown and described herein.

It should be appreciated that it is within the scope of the presentinvention to anteriorly place the first pedicle screw 12 on the leftanterior side 124, similar to that shown in FIG. 8 except the firstpedicle screw 12 is placed from the anterior instead of posterior of thevertebra 118. In fact, in some instances, anterior placement on the leftside may be advantageous. The reason that this placement may bepreferable is that the angle of the shaft 16 of the first pedicle screw12 is more shallow with respect to the first connecting screw 40. Thisshallower angle will require a smaller guide member 150 and result inthe surgery being performed in a smaller physical area. Since space islimited in the cavity of the patient, this configuration may be usefulin some circumstances. Also, anterior placement of the pedicle screw onthe left side may be utilized as a salvage when the right side becomesfractured or the desired stabilization is not obtained on the right sideof the vertebra 118.

FIG. 23 illustrates another aspect of the engaging portion 22 of thefirst pedicle screw 12 according to another aspect of the presentinvention. As previously discussed, depending upon the oblique angle ofplacement of the first pedicle screw 12 with respect to the vertebra118, the angle of engagement of the first connecting screw 40 with thefirst pedicle screw 12 may necessarily vary. For this reason, thepresent invention is further directed to an engaging opening 330 whereinthe engaging portion 22 is retained within the shaft 16 of the firstpedicle screw 12.

In this manner, the engaging portion 22 may be retained in the mannersuch that the engaging portion 22 may be rotated to receive the firstconnecting screw 40 at various angles 332. Although two angles 332 areshown, a variety of angles may be achieved utilizing the present aspectof the engaging portion 22. The engaging portion 22 may be retained onbearings or other floating structural devices within the engagingopening 330, such that when the first connecting screw 40 is coupledwith the engaging portion 22, the engaging portion 22 becomes fixed withrespect to the initial angle 332 of engagement.

Such variable positioning of the engaging portion 22 can further beobtained by a hinge or a latch connected to the engaging portion 22 forhinging or latching rotation at the engaging portion 22 within theengaging opening 330. Also, the engaging portion 22 may be provided on arotational or ratcheted body (not shown) within the engaging opening330. It will be appreciated that a wide variety of structures may beutilized for obtaining and achieving an engaging portion, such as theengaging portion 22 to obtain various angulations, such as the angles332 of connection of the first pedicle screw 12 relative to the firstconnecting screw 40 and are well known to those of ordinary skill in theart and are within the spirit and scope of the present invention and forbrevity will not be further discussed herein.

The advantage of the engaging portion 22 adapted for angular adjustmentis that it eliminates the need for a number of pedicle screws havingdifferent engaging portions with different angles for connection to thefirst connecting screw 40. However, it should be appreciated that inother aspects the engaging portion 22 is a fixed and rigid structure forengagement of the first connecting screw 40 and, as such, a plurality ofpedicle screws may be necessary each having a different angle ofengagement of the first connecting screw 40 at the engaging portion 22based upon the angle of placement of the first pedicle screw 12 in thevertebra 118.

Furthermore, according to other aspects of the present invention, it isanticipated that a variety of pedicle screws, such as the first pediclescrew 12, having significantly different lengths will be utilized forvarious adaptations and placements. Also, a variety of pedicle screws,such as the first pedicle screw 12, where the fixed engaging portion 22is available in variety of angles of connection of the connecting screwrelative to the shaft 16 of the first pedicle screw 12.

FIG. 24 illustrates another aspect of the present invention of the firstpedicle screw 12, wherein only a portion of the shaft 16 of the firstpedicle screw 12 is illustrated. In this aspect the shaft 16 is providedwith at least one non-continuous thread 336 extending circumferentiallyabout the shaft 16 of the first pedicle screw 12. In this manner, afirst portion 338 of the non-continuous threads 336 extendcircumferentially about a portion of the shaft 16 while a second portionof the non-continuous threads 336 extend about a second portion of theshaft 16.

A gap 342 is disposed between the first portion 338 and the secondportion 340 of the non-continuous threads 336. The gap is a portion ofthe shaft 16 that is not provided with threads and may be of variouscircumferential dimensions and be suitable for these purposes. It willbe appreciated that frequently the first pedicle screw 12 andparticularly the threads on the shaft 16 may cause aggravation andirritation to nerves adjacent the vertebra 18. Once it has beendetermined that a nerve is aggravated by the placement of the firstpedicle screw 12, adjustment or replacement of the first pedicle screw12 is necessitated. Frequently, this requires completely removing andrelocating the first pedicle screw 12 according to another oblique anglein the vertebra 118. By providing the first pedicle screw 12 having oneor more of the non-continuous threads 336, according to the presentaspect, aggravation of the nerve may be potentially alleviated by only aminor rotation of the first pedicle screw 12 since it is likely that thethread on the shaft 16 may be causing the irritation or aggravation ofthe nerve. Thus, upon a minor or slight rotation of the first pediclescrew 12 the gap 342 will replace, for example, the non-continuousthreads 336 and alleviate the aggravation of the nerve and, thus,eliminate the necessity for completely removing and repositioning thefirst pedicle screw 12. It will be appreciated that the position anddistribution of the non-continuous threads 336 with respect to theirsymmetrical placement may be altered or modified and are within thespirit and scope of the present invention as described and disclosedherein and will readily suggest themselves to one of ordinary skill inthe art.

FIG. 25 illustrates another aspect of the vertebral stabilizationassembly 10 having dual pedicle screws 400 a and 400 b for placement inthe vertebra 118 to provide additional stability. The pedicle screws 400a and 400 b are substantially similar to the first and second pediclescrews 12 and 14 in many aspects. The dual pedicle screws 400 a and 400b, however, are provided with engaging portions 402 a and 402 b relativeto one another such that a connecting screw 404, substantially similarto the first connecting screw 40, may be connected to both the dualpedicle screws 400 a and 400 b. The connecting screw 404 may be providedwith a first end 406 adapted to be received by the engaging portion 402a of the pedicle screw 400 a. The connecting screw 404 is furtherprovided with a shaft 408, at least a portion of which is operative toconnect to the engaging portion 402 b of the pedicle screw 400 b. Thedual pedicle screws 400 a and 400 b must be constructed and configuredsuch that upon placement in the vertebra 118 pedicle screws 400 a and400 b provide for such connection by the connecting screw 404.

In some aspects the engaging portion 402 b of the pedicle screw 400 bmay be an opening sufficient to receive the connecting screw 404 throughthe opening, as well as for engaging the shaft of 408 of the connectingscrew 404. It is readily apparent that this configuration of the dualpedicle screws 400 a and 400 b provides significant vertebral supportand stability. Furthermore, although only the vertebra 118 is shown itshould be understood that the present configuration, including the dualpedicle screws 400 a and 400 b and a connecting screw 404, may beutilized for placement in a plurality of vertebra to provide increasedstabilization for a plurality of vertebra for the purposes previouslydiscussed and disclosed herein.

In another aspect, the present invention provides a fixation tool 430for properly aligning the dual pedicle screws 400 a and 400 b forplacement in the vertebra 118. Accurate alignment and placement of thedual pedicle screws 400 a and 400 b, according to one aspect, may beadvantageously provided by utilizing the fixation tool 430. The fixationtool 430 is provided with alignment members 432 a and 432 b to achievethe proper alignment of the dual pedicle screws 400 a and 400 b in thevertebra 118. The alignment members 432 a and 432 b may be similar tothe alignment member 156 of the guide member 150 previously disclosedand described above.

It may be advantageous, according to other aspects, to provide indiciaon the dual pedicle screws 400 a and 400 b to provide for the properalignment of the pedicle screws 400 a and 400 b. In other aspects thefixation tool 430 may be unnecessary when employing x-ray, stealth, orother imaging technologies to ensure the accurate alignment andplacement of the dual pedicle screws 400 a and 400 b. In other aspects,however, the fixation tool 430 may be used such that the dual pediclescrews 400 a and 400 b may be simultaneously placed to ensure theengaging portions 402 a and 402 b of the dual pedicle screws 400 a and400 b, respectively, are in proper alignment for connection by theconnecting screw 404.

The pedicle screws 400 a and 400 b may also utilize guiding and locatingtechniques, previously discussed above, such that the pedicle screws 400a and 400 b may be placed posteriorly, percutaneously or otherwise, andthe connecting screw 404 may be placed anteriorly. Once the pediclescrews 400 a and 400 b have been inserted, the patient may then berotated. A guide member, such as the guide member 150 may be utilizedfor connection and alignment of the connecting screw 404, as previouslydiscussed above.

Thus, the guide member 150 is coupled, for example, to the pedicle screw400 a such that the alignment member 156 is operable to properly alignthe connecting screw 404 for coupling to the dual pedicle screws 400 aand 400 b. This may include, as previously discussed, drilling a taphole or other guiding hole for accurate placement and alignment of theconnecting screw 404. In any event, the connecting screw 404 may then beconnected to the dual pedicle screws 400 a and 400 b in a configurationsubstantially as illustrated in the present aspect.

FIG. 26 illustrates another aspect of the present invention utilizingdual pedicle screws 400 a and 400 b for anterior placement. It will beappreciated, as previously discussed, that one advantage of the presentinvention is placement of the pedicle screws from the anterior side 124of the vertebra 118. The current aspect illustrates anotherconfiguration of the fixation tool 430 having alignment members 432 aand 432 b for alignment of the dual pedicle screws 400 a and 400 b,respectively, from the anterior side 124 of the vertebra 118. Thefixation tool 430 may also combine the alignment features of the guidemember 150 (See FIG. 25) to achieve the proper alignment of theconnecting screw 404 as well.

In one aspect, the fixation tool 430 may be implemented by determiningthe point 440 on the vertebra 118 to desirably place the connectingscrew 404. A pin, tack or other means may be employed to position andorient the alignment portion 442 which will provide the proper alignmentfor the connecting screw 404. Once the desired placement for theconnecting screw 404 has been located, the dual pedicle screws 400 a and400 b may then be aligned and placed in the vertebra 118 utilizing thealignment members 432 a and 432 b of the alignment tool 430. In someaspects the alignment members 432 a and 432 b may be provided with aninner and an outer barrel (not shown) wherein the inner barrel may beutilized to drill a guide hole in the vertebra 118 and the outer barrelmay then be used to guide the pedicle screws 400 a and 400 b into place.

FIG. 27 illustrates another aspect of the present invention wherein theconnecting screw 404 may be placed across the body of the vertebra 118.In many instances it may be advantageous to position the connectingscrew 404 in such a manner for coupling of the connecting screw 404 toadjacent vertebra similarly stabilized. It is within the spirit andscope of the present invention that such placement of the connectingscrew 404 may still utilize the additional stability provided by one ormore pedicle screws 400 a and 400 b. The pedicle screw 400 b isillustrated in phantom to denote that such placement of the connectingscrew 404 may not necessitate placement of dual pedicle screws 400 a and400 b and only one pedicle screw 400 a may be sufficient to provide thedesired stability in these instances.

FIG. 28 illustrates another aspect of the vertebral stabilizationassembly 10 of the present invention. As referenced above, vertebralscrews (e.g., the pedicle screw 12 of FIG. 21) can vary in length. Withthis in mind, FIG. 28 is similar to the aspect of the inventiondescribed with reference to FIG. 21 except that the pedicle screw 12 isillustrated with a shorter length; additionally, the second end 64 ofthe first connecting screw 40 is within a recessed portion 119 of theanterior side 124 of the vertebra 118 (seen better in FIG. 29 anddiscussed below). Because of the shorter length of the pedicle screw 12,the pedicle screw 12 can enter the anterior portion 124 of the vertebra118 and traverse the vertebral body, but not enter the pedicle 120. Inother configurations, the pedicle screw 12 can extend partially into thepedicle 120; and, in yet further configurations, the pedicle screw 12can extend substantially into the pedicle 120 or near the pedicle 120.Thus, with the general label and use of the term “pedicle screw,” itshould be understood that a “pedicle screw” (e.g., pedicle screw 12)does not necessarily have to enter the pedicle 120. And, as such, theuse of the term “pedicle screw,” herein and by itself, should notrequire placement of the “pedicle screw” in the pedicle 120 unless thepedicle screw (e.g., pedicle screw 12) is specifically mentioned asbeing positioned within the pedicle 120. The pedicle screw 12 may alsobe referred to as a vertebral screw, a vertebral body screw, or ananterior vertebral screw.

FIG. 28 also shows that a head 60 of the pedicle screw 12 can be insetwithin the vertebra 118—that is, placed entirely or partially into thevertebra 118. This also can be seen more clearly in connection with FIG.29 where the head 60 may be inset or recessed into the recessed portion119.

With the general description of FIG. 28, it is intended that theplacement of the pedicle screw 12 in the anterior of the vertebra 118can avail itself of not only the techniques and devices described hereinwith reference to the remaining FIGURES, but also the techniques anddevices that will become apparent to one of ordinary skill in the artafter review of the specification herein—such techniques and devicesincluding not only those that are now known, but also those that arelater developed. For example, the configuration of FIG. 28 can utilizethe guide member 150 shown in FIG. 22.

It is further intended that any of the configurations, described hereinwith reference to the remaining FIGURES, can generally avail themselvesof the aspect of the invention, described with reference to FIG. 28. Forexample, the dual pedicle screws 400 a and 400 b of FIG. 26 can haveshorter lengths for placement in the vertebra 118, traversing throughthe vertebral body, but not through the pedicle 120. Additionally, thedual pedicle screw 400 a and 400 b of FIG. 26 can be inset into thevertebra 118.

FIG. 29 is a perspective view of the aspect of the invention describedwith reference to FIG. 28. FIG. 29, in general, shows a vertebra 118 anda second vertebra 34 with a vertebral stabilization assembly 10. FIG. 29is similar to the configuration of FIG. 1 except that the pedicle screws12 and 14 are shorter in length and inserted from an anterior side 124of the vertebra 118. A second end 64 of the first connecting screw 40and a second end 65 of the second connecting screw 42 are illustratedwithin recessed portions 119 of the anterior sides 124 of the vertebra118 and the second vertebra 34. In other implementations, the second end64 and the second end 65 may be countersunk or inset into the anteriorsides 124 of the vertebra 118 and the second vertebra 34.

The vertebral stabilization assembly 10 in this configuration includes afirst pedicle screw 12 and a second pedicle screw 14. The first pediclescrew 12 includes a shaft 16 provided with a threaded portion 18. Thethreaded portion 18 of the shaft 16 is operable for threading engagementof the first pedicle screw 12 with the vertebra 118. The shaft 16 of thepedicle screw 12 further includes an engaging portion 22.

The second pedicle screw 14 can be substantially similar to the firstpedicle screw 12 in that the second pedicle screw 14 can include a shaft30 substantially similar to the shaft 16 of the first pedicle screw 12.Additionally, the shafts 16 and 30 of the first and second pediclescrews 12 and 14, respectively, can be substantially cylindricalmembers. Similarly, the shaft 30 of the second pedicle screw 14 can beprovided with a threaded portion 32 similar to the threaded portion 18provided on the shaft 16 of the first pedicle screw 12. The threadedportion 32 of the shaft 30 is operable for threading engagement of thesecond pedicle screw 14 with a second vertebra 34. The shaft 30 of thesecond pedicle screw 14 is provided with an engaging portion 36.

The shafts 16 and 30 of the first and second pedicle screws 12 and 14can generally be a length that is sufficient to anchor the first pediclescrew 12 into the vertebra 118 and the second pedicle screw 14 into thevertebra 34. The lengths of the first pedicle screw 12 and the secondpedicle screw 14 as shown in FIG. 28 are relatively shorter whencompared to the lengths of the first pedicle screw 12 and the secondpedicle screw 14 in FIG. 1. The threaded portions 18 and 32 of the firstand second pedicle screws 12 and 14 may be threads similar to those onordinary screws and extending a distance from the shafts 16 and 30sufficient to promote optimum anchoring of the first and second pediclescrews 12 and 14 within the vertebra 118 and second vertebra 34. Thefirst and second pedicle screws 12 and 14 can be constructed of a rigidmaterial such as, but not limited to, steel, metal, or metal alloys,polymeric material, or a variety of other substantially rigid materialsadapted to promote rigid engagement of the first and second pediclescrews 12 and 14 to the vertebra 118 and second vertebra 34.

The first pedicle screw 12 (shown in ghosted view) extends through ananterior portion 124 of the vertebra 118 and traverses at least aportion of the vertebral body of the vertebra 118; however, the firstpedicle screw 12 does not extend into the pedicle 120 (better seen inFIG. 28). A head 60 of the first pedicle screw 12 may be inset withinthe vertebra 118. Likewise, the second pedicle screw 14 (shown inghosted view) extends through an anterior portion 124 of the secondvertebra 34 and traverses at least a portion of the vertebral body ofthe second vertebra 34; however, the second pedicle screw 14 does notextend into the pedicle 120 (better seen in FIG. 28). A head 67 of thesecond pedicle screw 14 may be inset within the second vertebra 34.While this configuration of the vertebral stabilization assembly 10 hasbeen described with reference to FIG. 28, it should be understood thatother configurations can additionally be utilized, including vertebralstabilization assemblies 10 with vertebral screws (e.g., pedicle screw12 and second pedicle screw 14), having different shapes,configurations, and sizes. For example, in other configurations, thevertebral screw can be inserted into the anterior portion 124 of thevertebra 118 and the second vertebra 34, traversing the vertebral body,and extending partially or substantially into the pedicle 120.Additionally, as referenced above, the anterior insertion of the firstpedicle screw 12 and second pedicle screw 14 into anterior portions 124of the vertebra 118 and/or the second vertebra 34 can allow use of avertebral screw with a larger diameter.

The vertebral stabilization assembly 10 is further provided with a firstconnecting screw 40 and a second connecting screw 42. The first andsecond connecting screws 40 and 42 can be substantially cylindricalmembers and may be constructed from materials similar to that of thefirst and second pedicle screws 12 and 14, such as, but not limited to,titanium, steel, metal or other metal alloys, substantially rigidpolymeric material or a variety of other rigid metallic materialsadapted and suitable for these purposes. The first connecting screw 40has a first end 44 and a second end 64. The second connecting screw 42has a first end 46 and a second end 65. The first end 44 of the firstconnecting screw 40 is adapted to be received by the engaging portion 22on the shaft 16 of the first pedicle screw 12. The first end 46 of thesecond connecting screw 42 is adapted to be received by the engagingportion 36 of the shaft 30 of the second pedicle screw 14.

The vertebral stabilization assembly 10 further includes a connectingmember 50 that has a first end 52 and a second end 54. The first end 52of the connecting member 50 is connected to or coupled near or adjacentthe second end 64 of the connecting screw 40 that is positionable in thevertebra 118. The second end 54 of the connecting member 50 is connectedto or coupled near or adjacent the second end 65 of the secondconnecting screw 42 positionable in the second vertebra 34. Theconnecting member 50 may be constructed from a variety of materialssimilar to that of the first and second pedicle screws 12 and 14 suchas, but not limited to, titanium, steel, metal, or other metal alloys,rigid polymeric material, or other rigid materials suitable forstabilization of the vertebra 118 and the second vertebra 34 byconnection to the first and second connecting screws 40 and 42.

The vertebra 118 and the second vertebra 34 of FIG. 29 have a naturalconcavely arced surface (that is, inwardly curved surface) or recessedportion 119 between edges 510 of the vertebra 118, and the secondvertebra 34. The second end 64 of the connecting screw 40 and the secondend 65 of the connecting screw 42 are positioned in the recessedportions 119 of the anterior sides 124 of the vertebra 118 and thesecond vertebra 34; and, as such, the first end 52 and second end 54 ofthe connecting member 50 are additionally positioned in the recessedportions 119 of the anterior sides 124 of the vertebra 118 and thesecond vertebra 34. To facilitate the connection of the first and secondends 52, 54 of the connecting member 50 (e.g., using a rod), edges 510on the vertebra 118 and the second vertebra 34 can have a groove,channel or cutout portion 500. The cutout portion 500 can be madeutilizing any techniques or equipment generally available for cuttingthe vertebra 118 and the second vertebra 34, including but not limitedto, drills, saws, chisels, and the like. In addition to the cutoutportion 500, it is additionally contemplated that if the memberconnecting the first and second ends 52, 54 of the connecting member 50would contact a disc portion, a portion of that disc could be cut out.Furthermore, while not shown, the recessed portion 119 can have aportion thereof cutout to allow all or at least a portion of theconnecting member 50 to be inset within the vertebra 118 and the secondvertebra 34. The placement of the second end 64, second end 65, firstend 52, and second end 54 in recessed portions 119 of the vertebra 118and second vertebra 34 minimizes or eliminates an excessive protrusionof the connecting member 50 away from the vertebra 118 and the secondvertebra 34. As such, the limited protruding prevents interruption withother bodily systems—e.g., blood vessels and the like.

With reference to FIG. 29, it is intended that any of theconfigurations, described with reference to other FIGURES, can generallyavail themselves of the aspect of the invention, described withreference to FIG. 29. For example, the first and second vertebrae 20 and34 of FIG. 1 can have a cutout portion 500 for placement of theconnecting member 50, therein.

It should be understood that the vertebra 118 and the second vertebra 34may be any vertebra or structure of the spine, such as, for example,lumbar, thoracic and cervical vertebrae.

Thus, it is apparent that there has been provided, in accordance withthe present invention, a vertebral stabilization assembly and methodthat satisfies one or more of the advantages set forth above. Althoughthe preferred embodiment has been described in detail, it should beunderstood that various changes, substitutions, and alterations can bemade herein without departing from the scope of the present invention,even if all of the advantages and benefits identified above are notpresent. For example, the various elements or components may be combinedor integrated in another system or certain features may not beimplemented. Also, the techniques, systems, sub-systems, and methodsdescribed and illustrated in the preferred embodiment as discrete orseparate may be combined or integrated with other systems, techniques,or methods without departing from the scope of the present invention.For example, any of the vertebral screws described herein can beutilized; and, the vertebral screws can be inserted from either ananterior or a posterior side of the vertebra. Other examples of changes,substitutions, and alterations are readily ascertainable by one skilledin the art and could be made without departing from the spirit and scopeof the present invention.

1. A vertebral stabilization assembly for stabilizing vertebrae, theassembly comprising: a first vertebral screw having a shaft providedwith a threaded portion operable for threading engagement of the firstvertebral screw with a vertebral body of a first vertebra, the shafthaving an engaging portion; a first connecting screw having a first endand a second end, the first end adapted to be received by the engagingportion of the first vertebral screw; a second vertebral screw having ashaft provided with a threaded portion operable for threading engagementof the second vertebral screw with a vertebral body of a secondvertebra, the shaft having an engaging portion; a second connectingscrew having a first end and a second end, the first end adapted to bereceived by the engaging portion of the second vertebral screw; and aconnecting member having a first end, a second end, a first location anda second location, wherein: the connecting member is configured to allowa limited degree of movement between the vertebrae; the connectingmember is operable to couple with the first connecting screwpositionable in the first vertebra at the first location of theconnecting member; and the connecting member is operable to couple withthe second connecting screw positionable in the second vertebra at thesecond location of the connecting member for stabilization of the firstvertebra and the second vertebra.
 2. The vertebral stabilizationassembly of claim 1, further comprising: an artificial disc disposedbetween the first vertebra and the second vertebra.
 3. The vertebralstabilization assembly of claim 1, further comprising: a third vertebralscrew having a shaft provided with a threaded portion operable forthreading engagement of the third vertebral screw with a vertebral bodyof a third vertebra, the shaft having an engaging portion; and a thirdconnecting screw having a first end and a second end, the first endadapted to be received by the engaging portion of the third vertebralscrew, wherein: the connecting member has a third location; and theconnecting member is operable to couple with the third connecting screwpositionable in the third vertebra at the third location of theconnecting member for stabilization of the third vertebra with the firstand second vertebra.
 4. The vertebral stabilization assembly of claim 3,wherein the connecting member is a cable.
 5. The vertebral stabilizationassembly of claim 1, wherein the connecting member is a plurality ofconnecting members.
 6. The vertebral stabilization assembly of claim 1,wherein the connecting member is made of flexible material.
 7. Thevertebral stabilization assembly of claim 6, wherein the connectingmember is defined as a flexible rod.
 8. The vertebral stabilizationassembly of claim 1, wherein the first vertebral screw is operable to bepositioned in the first vertebra from an anterior side of the firstvertebra into the vertebral body of the first vertebra, and the secondvertebral screw is operable to be positioned in the second vertebra froman anterior side of the second vertebra into the vertebral body of thesecond vertebra.
 9. The vertebral stabilization assembly of claim 1,wherein the connecting member connected to the first and secondconnecting screw is sized to retain the first vertebra a distance fromthe second vertebra.
 10. The vertebral stabilization assembly of claim1, wherein the connecting member is defined as a bracket.
 11. Thevertebral stabilization assembly of claim 1, wherein the connectingmember is defined as a plate.
 12. The vertebral stabilization assemblyof claim 8, wherein the first vertebral screw is operable to bepositioned through the vertebral body of the first vertebra and into apedicle portion of the first vertebra, and the second vertebral screw isoperable to be positioned through the vertebral body of the secondvertebra and into a pedicle portion of the second vertebra.
 13. Thevertebral stabilization assembly of claim 8, wherein the first vertebralscrew is operable to be positioned through the vertebral body of thefirst vertebra but not into a pedicle portion of the first vertebra, andthe second vertebral screw is operable to be positioned through thevertebral body of the second vertebra but not into a pedicle portion ofthe second vertebra.
 14. The vertebral stabilization assembly of claim1, wherein the first vertebral screw is a first anterior vertebralscrew, and the second vertebral screw is a second anterior vertebralscrew.
 15. The vertebral stabilization assembly of claim 1, wherein thefirst vertebral screw is a first pedicle screw, and the second vertebralscrew is a second pedicle screw.
 16. The vertebral stabilizationassembly of claim 1, wherein the connecting member is coupled to thefirst connecting screw adjacent the second end of the first connectingscrew, wherein the connecting member is coupled to the second connectingscrew adjacent the second end of the second connecting screw.
 17. Thevertebral stabilization assembly of claim 16, wherein the first locationof the connecting member is at the first end of the connecting member,wherein the second location of the connecting member is at the secondend of the connecting member.
 18. The vertebral stabilization assemblyof claim 1, wherein the connecting member is coupled to the firstconnecting screw at the second end of the first connecting screw,wherein the connecting member is coupled to the second connecting screwat the second end of the second connecting screw.
 19. A method forstabilizing a lower vertebra and an upper vertebra from an anterior sideof the vertebrae using a vertebral stabilization assembly, the methodcomprising: inserting a first vertebral screw, which includes a shaftprovided with a threaded portion operable to threadingly engage thelower vertebra, into the lower vertebra such that a portion of thethreaded portion of the shaft engages a vertebral body portion of thelower vertebra, the shaft of the first vertebral screw having anengaging portion; inserting a first end of the first connecting screwinto the engaging portion of the first vertebral screw; inserting asecond vertebral screw, which includes a shaft provided with a threadedportion operable to threadingly engage the upper vertebra, into theupper vertebra such that a portion of the threaded portion of the shaftengages a vertebral body portion of the upper vertebra, the shaft of thesecond vertebral screw having an engaging portion; inserting a first endof the second connecting screw into the engaging portion of the secondvertebral screw; positioning a connecting member on an anterior side ofthe upper vertebra and the lower vertebra; coupling a connecting memberto a second end of the first connecting screw and to a second end of thesecond connecting screw; and allowing a limited degree of movementbetween the upper and lower vertebra via an arrangement of theconnecting member.
 20. The method of claim 19, further comprising:inserting an artificial disc between the lower vertebra and the uppervertebra.
 21. The method of claim 19, wherein: the first vertebral screwis inserted from an anterior side of the lower vertebra and is operableto be positioned through the vertebral body of the lower vertebra andinto a pedicle portion of the lower vertebra, and the second vertebralscrew is inserted from an anterior side of the upper vertebra and isoperable to be positioned through the vertebral body of the uppervertebra and into a pedicle portion of the upper vertebra.
 22. Themethod of claim 20, wherein: the first vertebral screw is inserted froman anterior side of the lower vertebra and is operable to be positionedthrough the vertebral body of the lower vertebra but not into a pedicleportion of the lower vertebra, and the second vertebral screw isinserted from an anterior side of the upper vertebra and is operable tobe positioned through the vertebral body of the upper vertebra but notinto a pedicle portion of the upper vertebra.